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

2451–2475 of 3297

Cleared Jul 20, 1984

SICKLE CELL REAGENT SET

K842368 · Livonia Diagnostics, Inc.

GHM · Test, Sickle Cell · 35d

Cleared Jul 19, 1984

DANAM ELEC. SA-1000

K840649 · Danam Electronics

GKL · Counter, Cell, Automated (particle Counter) · 155d

Cleared Jul 19, 1984

MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII

K841708 · Meloy Laboratories, Inc.

GGP · Test, Qualitative And Quantitative Factor Deficiency · 87d

Cleared Jul 19, 1984

BOVINE THROMBIN, HUMAN THROMBIN

K841956 · Haemachem, Inc.

GJA · Test, Thrombin Time · 66d

Cleared Jul 19, 1984

BOVINE FACTOR XA-HUMAN FACTOR XA

K841957 · Haemachem, Inc.

GGP · Test, Qualitative And Quantitative Factor Deficiency · 66d

Cleared Jul 02, 1984

IDI ISOTONIC DILUENT

K842068 · Interscience Diagnostics, Inc.

GIF · Diluent, Blood Cell · 40d

Cleared Jul 02, 1984

IDL-LYSING REAGENT

K842069 · Interscience Diagnostics, Inc.

GGK · Products, Red-cell Lysing Products · 40d

Cleared Jul 02, 1984

K842070 · Interscience Diagnostics, Inc.

PPM · General Purpose Reagent · 40d

Cleared Jun 26, 1984

K842017 · Streck Laboratories, Inc.

JPK · Mixture, Hematology Quality Control · 39d

Cleared Jun 11, 1984

QUICK-COUNT PLUS 2

K841504 · Seragen Diagnostics, Inc.

GKL · Counter, Cell, Automated (particle Counter) · 62d

Cleared Jun 01, 1984

K841365 · Diatech, Inc.

GIR · Reagent, Russel Viper Venom · 60d

Cleared Jun 01, 1984

K841366 · Diatech, Inc.

KQJ · System, Fibrinogen Determination · 60d

Cleared Jun 01, 1984

HEPARIN COAGULATION CONTROL PLASMA 1-

K841462 · Diatech, Inc.

JPA · System, Multipurpose For In Vitro Coagulation Studies · 53d

Cleared Jun 01, 1984

OWREN'S VERONAL BUFFERR

K841523 · Diatech, Inc.

JPA · System, Multipurpose For In Vitro Coagulation Studies · 50d

Cleared May 31, 1984

CYANOMETHEMOGLOBIN REAGENT

K841799 · Reagent Laboratory, Inc.

GIF · Diluent, Blood Cell · 43d

Cleared May 31, 1984

LYSING & HEMOGLOBIN REAGENT

K841800 · Reagent Laboratory, Inc.

GGK · Products, Red-cell Lysing Products · 43d

Cleared May 31, 1984

K841848 · R&D Systems, Inc.

KQC · Stains, Hematology · 64d

Cleared May 25, 1984

HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM

K841021 · Hemotec, Inc.

JOX · Analyzer, Heparin, Automated · 74d

Cleared May 21, 1984

SODIUM CHLORIDE SOLUTION BLOOD CELL

K841183 · Reagent Laboratory, Inc.

FNW · Pad, Kelly · 62d

Cleared May 14, 1984

K840828 · Kyoto Diagnostics, Inc.

JMT · Diazo (colorimetric), Nitrite (urinary, Non-quant) · 80d

Cleared May 11, 1984

ULTRACLONE ECL-01-800 CELL LINE

K841337 · Earl-Clay Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 39d

Cleared May 11, 1984

ULTRACLONE ECL-01-600 CELL LINE

K841338 · Earl-Clay Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 39d

Cleared May 11, 1984

ULTRA CLONE ECL-01-700 CELL LINE

K841339 · Earl-Clay Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 39d

Cleared May 11, 1984

ULTRACLONE ECL-01-500 CELL LINE

K841345 · Earl-Clay Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 39d

Cleared May 11, 1984

ULTRACLONE ECL-01-200 CELL LINE

K841346 · Earl-Clay Laboratories, Inc.

KIR · Cells, Animal And Human, Cultured · 39d

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