Data Medical Associates, Inc.
United StatesFDA applicant, unverified
- Devices
- 111
What Data Medical Associates, Inc. makes
Data Medical Associates, Inc. manufactures diagnostic reagents and procedures for clinical chemistry analyzers, including hemoglobin controls, glucose hexokinase assays, triglyceride tests, and procedures for measuring magnesium, total cholesterol, gamma-glutamyl transferase (GGT), blood urea nitrogen (BUN), direct bilirubin, uric acid, and iron levels.
The company’s portfolio consists of Class I and Class II devices, with several procedures listed via the FDA’s 510(k) pathway. These products are intended for use in laboratory settings to support biochemical and hematological testing. The manufacturer is based in the United States.
AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Lactate Dehydrogenase (Ld) Procedure Ref K861662
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISodium, Potassium And Chloride Procedure Ref K861669
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITotal Protein Procedure Ref K863258
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITriglyceride (Trinder) Procedure Ref K861670
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDma Unsaturated Iron Binding Capacity Procedure Ref K946354
Active Regimes: 510(k) Registry: 510(k) ClassClass:ITotal Bilirubin Procedure Ref K955300
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICreatine Kinase (Ck) Isoenzyme Mb Ref K881168
Active Regimes: CE IVDD 510(k) Registry: 510(k) ClassClass:IIUnsaturated Iron Binding Capacity Ref K881761
Active Regimes: 510(k) Registry: 510(k) ClassClass:IData-Zyme Glucose Hexokinase Colozimetri Ref K801051
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITotal Bilirubin Standards Ref K852068
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICreatine Phrosphokinase (Ck) Procedure Ref K861665
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIData-Zyme Lat(Gpt) Procedure Ref K801857
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Chloride Procedure Ref K863585
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDirect Bilirubin Procedure Ref K863265
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDirect Bilirubin Procedure Ref K861671
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBlood Urea Nitrogen (Bun) Procedure Ref K861666
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIInorganic Phosphorus Procedure Ref K861661
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAmylase Colorimetric Procedure Ref K864825
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAst/Got Procedure Ref K861656
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICholesterol Procedure Ref K863252
Active Regimes: 510(k) Registry: 510(k) ClassClass:ITriglyceride(Trinder) Procedure Ref K851538
Active Regimes: 510(k) Registry: 510(k) ClassClass:IHdl-C/Ldl-C Calibrator, Model 1913-003 Ref K993098
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICholesterol Procedure Ref K861659
Active Regimes: 510(k) Registry: 510(k) ClassClass:IDate Chem Inorganic Phosphorous U.V. Procedure Ref K850986
Active Regimes: 510(k) Registry: 510(k) ClassClass:IData-Zyme Triglyceride Ref K810965
Active Regimes: 510(k) Registry: 510(k) ClassClass:IData-Zyme Urea Nitrogen, Colorimetric Ref K801727
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIData-Zyme Acia Phosphatase Procedure Ref K790524
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIData Chem Iron Procedure Ref K852583
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAmylase Products Ref K850798
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDma Amylase (Demand) Procedure Ref K940010
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMagnesium Procedure Ref K863267
Active Regimes: 510(k) Registry: 510(k) ClassClass:IUric Acid Procedure Ref K863251
Active Regimes: 510(k) Registry: 510(k) ClassClass:IGlucose Oxidase Procedure Ref K861204
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICalcium Procedure Ref K861657
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIData-Zyme Alkaline Phosphatase Proced Ref K831360
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAlt/Gpt Procedure Ref K861658
Active Regimes: 510(k) Registry: 510(k) ClassClass:ILactate Dehydrogenase(Ld) Procedure Ref K863255
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDma Glucose Hexokinase U.V. Procedure Ref K952437
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITriglyceride (Trinder) Procedure Ref K863254
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAlkaline Phosphatase Procedure Ref K861667
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILactate Dehydrogenase Isoenzyme 1 Ref K872891
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITotal Protein Procedure Ref K861663
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIData Zyme Acid Phosphatase Procedure Ref K850902
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDma Albumin Procedure Ref K946355
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBicarbonate Procedure Ref K861673
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDma Calibrators Ref K854092
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIron Calibrator & Calibration Verification Set Ref K955796
Active Regimes: 510(k) Registry: 510(k) ClassClass:ITotal Iron Binding Capacity Procedure Ref K861602
Active Regimes: 510(k) Registry: 510(k) ClassClass:ITotal Bilirubin Procedure Ref K863262
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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