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
Cleared
May 07, 1984
PARAGON ACID HEMOGLOBIN REAGENT KIT
GKA
Abnormal Hemoglobin Quantitation
129d
Cleared
May 07, 1984
CENTRIFUGES
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
74d
Cleared
May 02, 1984
CELLTRAK-B
FRZ
Device, Patient Transfer, Powered
125d
Cleared
May 02, 1984
FIBRINOGEN ASSAY KIT
KQJ
System, Fibrinogen Determination
51d
Cleared
May 02, 1984
ASSIGNED VALUE FOR MEAN PLATELET
JPK
Mixture, Hematology Quality Control
40d
Cleared
May 02, 1984
COAGULATION CONTROL PLASMA LEVEL 1/2/3
GGP
Test, Qualitative And Quantitative Factor Deficiency
23d
Cleared
May 01, 1984
DIA THROMBIN DIA PLASTIN
GJS
Test, Time, Prothrombin
68d
Cleared
May 01, 1984
BIOSURE
JJW
Urinalysis Controls (assayed And Unassayed)
67d
Cleared
Apr 30, 1984
FACS ANALYZER
GKZ
Counter, Differential Cell
103d
Cleared
Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA II
GGP
Test, Qualitative And Quantitative Factor Deficiency
59d
Cleared
Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA VIII
GGP
Test, Qualitative And Quantitative Factor Deficiency
59d
Cleared
Apr 30, 1984
CALCIUM CHLORIDE
GGW
Test, Time, Partial Thromboplastin
18d
Cleared
Apr 25, 1984
DIA-H 1/2/3 & DIA-HT 1/2/3
62d
Cleared
Apr 25, 1984
COAGULATION FACTOR V DEFICIENT SUBSTR
GGP
Test, Qualitative And Quantitative Factor Deficiency
23d
Cleared
Apr 23, 1984
REPTILASE-R HA35
JCO
Bothrops Atrox Reagent
95d
Cleared
Apr 23, 1984
DIACELIN
GGN
Plasma, Coagulation Control
90d
Cleared
Apr 19, 1984
DADE HEMATOLOGY CALIBRATOR PLUS
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
106d
Cleared
Apr 19, 1984
KYOTEST UGK
JIL
Method, Enzymatic, Glucose (urinary, Non-quantitative)
55d
Cleared
Apr 17, 1984
RUBAQUICK DIAGNOSTIC KIT
GOL
Antigen, Ha (including Ha Control), Rubella
147d
Cleared
Apr 17, 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
GKL
Counter, Cell, Automated (particle Counter)
62d
Cleared
Apr 17, 1984
HAEMOFUGE A. BIOFUGE A. & B
JPI
Device, Hematocrit Measuring
54d
Cleared
Apr 13, 1984
SICKLE-STAT HEMOGLOBIN S SCREEN KIT
GHM
Test, Sickle Cell
17d
Cleared
Apr 05, 1984
RISTOCETIN COFACTOR ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
71d
Cleared
Apr 04, 1984
PARAMAX ACID PHOSPHATASE REAGENT
CKB
Acid Phosphatase, Naphthyl Phosphate
49d
Cleared
Apr 04, 1984
ASPARTATE AMINOTRANSFERASE REAGENT
CIT
Nadh Oxidation/nad Reduction, Ast/sgot
47d
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