FDA Review Panel · HE

FDA 510(k) Hematology Devices

FDA 510(k) Hematology Devices - Regulatory Overview

FDA 510(k) hematology devices include automated instruments used to analyze blood composition and coagulation. The FDA review panel code is HE.

Key device categories:

Complete blood count (CBC) analyzers - automated cell counters for RBC, WBC and platelets
Coagulation analyzers - PT/INR, aPTT, fibrinogen and factor assays
Flow cytometry systems - immunophenotyping and cell sorting
Blood typing and cross-match systems - transfusion medicine instruments

Most hematology devices are classified as Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.

3297

Total

3290

Cleared

164d

Avg (2y)

1976

Since

3297 Hematology devices

2401–2425 of 3297

Cleared Oct 31, 1984

ULTRAXLONE ECL-01-1000 CELL LINE

K843577 · Earl-Clay Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 50d

Cleared Oct 31, 1984

ULTRACLONE ECL-01-2100 CELL LINE

K843578 · Earl-Clay Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 50d

Cleared Oct 31, 1984

ULTRACLONE ECL-01-1100

K843579 · Earl-Clay Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 50d

Cleared Oct 31, 1984

SIGMA SUDAN BLACK REAGENT 380-1

K843684 · Sigma Chemical Co.

HZZ · Sudan Black B · 43d

Cleared Oct 30, 1984

K843619 · R&D Systems, Inc.

KQC · Stains, Hematology · 46d

Cleared Oct 30, 1984

SIGMA PERIODIC ACID-SCHIFF STAIN 395

K843752 · Sigma Chemical Co.

HZT · Reagent, Schiff · 35d

Cleared Oct 23, 1984

K842818 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JCF · Lymphocyte Separation Medium · 97d

Cleared Oct 23, 1984

K843093 · Streck Laboratories, Inc.

JPK · Mixture, Hematology Quality Control · 77d

Cleared Oct 23, 1984

K843207 · Bio/Data Corp.

JCO · Bothrops Atrox Reagent · 69d

Cleared Oct 23, 1984

BLOOD DILUTION VIAL

K844042 · American Scientific Products

GKL · Counter, Cell, Automated (particle Counter) · 6d

Cleared Oct 18, 1984

FRESENIUS HAEMODIALYSIS A2008

K843014 · Seratronics, Inc.

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 79d

Cleared Oct 17, 1984

K842717 · Roche Diagnostic Systems, Inc.

JPA · System, Multipurpose For In Vitro Coagulation Studies · 96d

Cleared Oct 15, 1984

GLYCO-TEK AFFINITY COLUMN

K842689 · Helena Laboratories

LCP · Assay, Glycosylated Hemoglobin · 97d

Cleared Oct 01, 1984

VON WILLEBRAND FACTOR ANTIGEN SCREEN

K842537 · American Dade

ICF · Crystal Violet For Histology · 95d

Cleared Oct 01, 1984

VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT

K842617 · American Dade

GGP · Test, Qualitative And Quantitative Factor Deficiency · 88d

Cleared Oct 01, 1984

HYCEL DILUTOR, VARIOUS MODELS/MULTI

K842747 · R&D Systems, Inc.

GKH · Apparatus, Automated Blood Cell Diluting · 80d

Cleared Sep 21, 1984

DRABKIN REAGENT

K842931 · E K Ind., Inc.

KAG · Holder, Speculum, Ent · 58d

Cleared Sep 21, 1984

K843361 · Medical Technomics, Ltd.

GIO · Tube, Collection, Capillary Blood · 24d

Cleared Sep 21, 1984

K843362 · Medical Technomics, Ltd.

GIO · Tube, Collection, Capillary Blood · 24d

Cleared Sep 14, 1984

ACETIC ACID 1% V/V

K842938 · E K Ind., Inc.

GGK · Products, Red-cell Lysing Products · 51d

Cleared Sep 12, 1984

ACETIC ACID, 5% V/V

K842935 · E K Ind., Inc.

GGK · Products, Red-cell Lysing Products · 49d

Cleared Sep 12, 1984

ACETIC ACID, 3% V/V

K842936 · E K Ind., Inc.

GGK · Products, Red-cell Lysing Products · 49d

Cleared Sep 12, 1984

ACETIC ACID 2% V/V

K842937 · E K Ind., Inc.

GGK · Products, Red-cell Lysing Products · 49d

Cleared Sep 11, 1984

DIA T1, T2 & T3

K842286 · Diatech, Inc.

JPK · Mixture, Hematology Quality Control · 90d

Cleared Sep 09, 1984

SICKLING HEMOGLOBIN CONTROLS, NORMAL

K842152 · Isolab, Inc.

GHM · Test, Sickle Cell · 102d

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