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
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 24, 1987
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
GKZ
Counter, Differential Cell
61d
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
Cleared
May 20, 1987
S-CAL HEMATOLOGY CALIBRATOR
KRY
Calibrator For Platelet Counting
351d
Cleared
May 20, 1987
URINOSCOPY FUNNEL
GHO
Hemocytometer
22d
Cleared
Apr 28, 1987
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
LCP
Assay, Glycosylated Hemoglobin
153d
Cleared
Apr 28, 1987
CLEARVIEW CW-10
GKR
System, Hemoglobin, Automated
98d
Cleared
Apr 23, 1987
PT HEPARIN ADSORBENT
JPA
System, Multipurpose For In Vitro Coagulation Studies
56d
Cleared
Apr 23, 1987
PROTEIN S CONTROL PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
48d
Cleared
Apr 20, 1987
PROTHROMBIN TIME TEST
GJS
Test, Time, Prothrombin
69d
Cleared
Apr 20, 1987
COAGULATION CONTROL, LEVEL I
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Apr 20, 1987
COAGULATION CONTROL, LEVEL II
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Apr 20, 1987
COAGULATION CONTROL, LEVEL III
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Apr 15, 1987
CYANMETHEMOGLOBIN STANDARD
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
15d
Cleared
Apr 14, 1987
CHEMPRO 1000(TM)
GKF
Instrument, Hematocrit, Automated
42d
Cleared
Mar 31, 1987
SYSTEM 9000 AUTOMATED CELL COUNTER
GKL
Counter, Cell, Automated (particle Counter)
48d
Cleared
Mar 31, 1987
O.O2 M CALCIUM CHLORIDE SOLUTION
JPA
System, Multipurpose For In Vitro Coagulation Studies
40d
Cleared
Mar 31, 1987
HL-1 SUPPLEMENT
KIT
Media And Components, Synthetic Cell And Tissue Culture
28d
Cleared
Mar 30, 1987
VWF IMMUNOBLOT
GGP
Test, Qualitative And Quantitative Factor Deficiency
118d
Cleared
Mar 25, 1987
MSI HEMATOLOGY CONTROL +
JPK
Mixture, Hematology Quality Control
7d
Cleared
Mar 23, 1987
WINPETTE
JPH
Test, Erythrocyte Sedimentation Rate
5d
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