Coulter Electronics, Inc.

United StatesFDA 510(k) applicant, unverified

Devices: 101

What Coulter Electronics, Inc. makes

Coulter Electronics, Inc. manufactures in vitro diagnostic devices for hematology and clinical chemistry, including automated cell counters, differential leukocyte analyzers, and reagent systems for measuring platelet volume, cholesterol, HDL cholesterol, and phenytoin levels. Their portfolio also includes specialized calibrators and immunoassay reagents for laboratory use.

The company’s devices are classified under FDA’s Class I and Class II categories, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory clearance in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue101

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What Coulter Electronics, Inc. makes

Catalogue101

Coulter Ld (Ldh-L) Reagent Ref K897164

Coulter Counter Model S Plus Ref K792537

4C Abnormal Low-High (8 X 6 M1) Ref K760682

Coulter Counter Model T-540 Ref K863085

Coulter Counter Model M5 Ref K853429

Coulter Counter Model M4 Ref K843303

S-Cal Hematology Calibrator Ref K840794

Thyro-Zyme-T4 Assay Kit Ref K780401

Coulter Stks Ref K885093

Coulter MH009 Ref K922181

Coulter Triglycerides Gpo Reagent Ref K897159

Coulter Double Check, Unassayed Serum Chemistry Ref K851942

Coulter Electrolyte Analyzer System Ref K781528

NDC#12739-0011-1 C-Zyme Got Ref K760193

Coulter Ck-Mb Isoenzyme Reagent Ref K904866

Dart Gamma-Gt Reagent System Ref K834054

Kem-O-Mat Ref K771513

Coulter Channelyzer 256 Ref K851736

Leukocyte Vol. Analysis Apparatus Ref K802208

Dart Ck-Mb Reagent System Ref K854708

Enzymatic Reagent For Cholesterol Meas Ref K781013

Coulter Dart Ck-Mb Isoenzyme Reagent System Ref K872041

Coulter Accu-Zyme Ii Got Reagent Ref K790483

Coulter Accu-Zyme Iiy-Gt Reagent Kit Ref K790812

Hc Plus Ref K833563

Coulter Dart Alt (Gpt) Reagent Ref K905767

Coulter Counter Model T-660 Ref K854114

Coulter Counter M2 Ref K834568

Dart Alpha-Amylase Reagent System Ref K834053

Coulter Check Sample Unassayed Hematolog Ref K843805

Dart Digoxin Assay Ref K864802

Blood, Hematology Reference Control Ref K781969

Coulter MH017 Ref K921567

CD8 Cytospheres Kit Ref K923951

Modified Blood Cell Counting & Lysing Ref K801357

Coulter Immunoprep Leukocyte/Q-Prep Immuno Wrk Sta Ref K874188

Coulter 5P Control Ref K885028

Coulter Dart Ast (Got) Reagent Ref K905771

Dart Iron & Iron Binding Capacity Reagent Ref K854305

Coulter Flow Reticulocyte Reagent Ref K885332

Coulter Counter Model S-Plus Stkr Ref K871837

E-Z Prep Ref K831558

S-Cal Hematology Calibrator Ref K862122

Assay, Amphet. NDC#11711-0127-1 Coulter Ref K760196

Dart Phenobarbital Assay System Ref K864612

Coulter Multi-Q-Prep Ref K923530

Coulter Glucose Reagent Ref K897160

Coulter Viscometer Ii Ref K883503

Coulter-Counter #s Plus Iv & Lyse S +d Ref K823355

Coulter Volume Adapter Ref K851943