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.
3293
Total
3286
Cleared
158d
Avg (2y)
1976
Since
1855 Hematology devices
Cleared
Nov 20, 1987
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
JJQ
Colorimeter, Photometer, Spectrophotometer For Clinical Use
88d
Cleared
Nov 04, 1987
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT
JMG
Radioimmunoassay (two-site Solid Phase), Ferritin
50d
Cleared
Nov 04, 1987
FALSE RAGWEED ALLERGEN DISC
DHB
System, Test, Radioallergosorbent (rast) Immunological
22d
Cleared
Oct 20, 1987
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
GIO
Tube, Collection, Capillary Blood
41d
Cleared
Oct 20, 1987
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
GGK
Products, Red-cell Lysing Products
15d
Cleared
Oct 02, 1987
LEUCOPREP BRAND TUBE
JCF
Lymphocyte Separation Medium
80d
Cleared
Sep 30, 1987
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
GKL
Counter, Cell, Automated (particle Counter)
117d
Cleared
Sep 29, 1987
QBC VENOUS BLOOD CONTROL/MULTIPLE
JPK
Mixture, Hematology Quality Control
40d
Cleared
Sep 23, 1987
TURBOX
JZW
Nephelometer
30d
Cleared
Sep 15, 1987
MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
DBT
Factor Xiii A, S, Antigen, Antiserum, Control
98d
Cleared
Sep 14, 1987
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
KPA
Slide Stainer, Automated
52d
Cleared
Sep 11, 1987
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
LJX
Test, Urine Leukocyte
24d
Cleared
Aug 28, 1987
TECHNICON H*1 JR.(TM) SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
21d
Cleared
Aug 27, 1987
PROTHROMBIN TIME TEST
GJS
Test, Time, Prothrombin
63d
Cleared
Aug 21, 1987
ASSERACHROM PROTEIN S TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
59d
Cleared
Aug 06, 1987
DATA-FI DIMERTEST LATEX ASSAY
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
59d
Cleared
Aug 06, 1987
THROMBOREL S
GJS
Test, Time, Prothrombin
17d
Cleared
Jul 23, 1987
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
KHG
Whole Blood Hemoglobin Determination
16d
Cleared
Jul 09, 1987
CHROM-TROL
JPA
System, Multipurpose For In Vitro Coagulation Studies
20d
Cleared
Jul 06, 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
LCP
Assay, Glycosylated Hemoglobin
90d
Cleared
Jul 06, 1987
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
GHH
Fibrin Split Products
18d
Cleared
Jul 02, 1987
COULTER COUNTER MODEL S-PLUS STKR
GKZ
Counter, Differential Cell
51d
Cleared
Jun 10, 1987
Q.I.C. BLEEDING TIME DEVICE
JCA
Device, Bleeding Time
68d
Cleared
Jun 01, 1987
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
JPA
System, Multipurpose For In Vitro Coagulation Studies
90d
Cleared
May 21, 1987
STACHROM PROTEIN C TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
65d
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