Datachem, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Datachem, Inc. makes
Datachem, Inc. manufactures blood and fluid warmers, including the FLO TEM II and a generic fluid warmer, designed to raise the temperature of intravenous fluids and blood products during medical procedures. The company also produces clinical diagnostic analyzers, such as the APSARA Analyzer and its modified version, which assess blood chemistry and provide diagnostic information for clinical use.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These analyzers and warmers are listed in the FDA’s 510(k) database, reflecting their regulatory clearance status. Datachem, Inc. is based in the United States.
Catalogue
Flo Tem Ii (Blood/Fluid Warmer Ref K813161
Regimes: 510(k) Registry: 510(k)Apsara Analyzer Ref K834534
Regimes: 510(k) Registry: 510(k)Modified Apsara Clinical Diagnostic Analyzer Ref K900788
Regimes: 510(k) Registry: 510(k)Fluid Warmer Ref K803249
Regimes: 510(k) Registry: 510(k)Apsara Clinical Diag. & Info. Sys Ref K823386
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Datachem, Inc. have in the registry?
The registry currently lists 5 devices for Datachem, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Datachem, Inc.'s devices?
Among its 5 most recently registered devices, Datachem, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Datachem, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Datachem, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Datachem, Inc. in the registry?
The most recently registered devices listed for Datachem, Inc. include FLO TEM II (BLOOD/FLUID WARMER, APSARA ANALYZER, MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER and FLUID WARMER.