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
Nov 12, 1985
21 HEMATOLOGY REAGENTS
GKZ
Counter, Differential Cell
99d
Cleared
Nov 12, 1985
THROMBOPLASTIN-R REAGENT
JPA
System, Multipurpose For In Vitro Coagulation Studies
46d
Cleared
Nov 12, 1985
LEUCO PREP
JCF
Lymphocyte Separation Medium
36d
Cleared
Nov 05, 1985
COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE
JPA
System, Multipurpose For In Vitro Coagulation Studies
228d
Cleared
Nov 05, 1985
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
GKL
Counter, Cell, Automated (particle Counter)
110d
Cleared
Nov 05, 1985
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
KFF
Assay, Heparin
96d
Cleared
Nov 05, 1985
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
JPA
System, Multipurpose For In Vitro Coagulation Studies
89d
Cleared
Nov 05, 1985
COULTER COUNTER MODEL T-660
GKL
Counter, Cell, Automated (particle Counter)
28d
Cleared
Nov 05, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
KHG
Whole Blood Hemoglobin Determination
26d
Cleared
Oct 31, 1985
THROMBO SCREEN SICKLE CELL ASSAY SET
GHM
Test, Sickle Cell
24d
Cleared
Oct 31, 1985
MICRO-MAT SYSTEM
GKJ
Spinner, Slide, Automated
22d
Cleared
Oct 10, 1985
FDP ASSAY-20 TEST KIT
GHH
Fibrin Split Products
97d
Cleared
Oct 10, 1985
PARA CHECK (AKA EIGHT CHECK-C)
JPK
Mixture, Hematology Quality Control
87d
Cleared
Oct 10, 1985
COULTER COUNTER MODEL M5
GKL
Counter, Cell, Automated (particle Counter)
56d
Cleared
Oct 10, 1985
CITREX H
GGW
Test, Time, Partial Thromboplastin
20d
Cleared
Oct 04, 1985
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
GHH
Fibrin Split Products
109d
Cleared
Oct 04, 1985
ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES
JPA
System, Multipurpose For In Vitro Coagulation Studies
66d
Cleared
Oct 04, 1985
ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR
JPA
System, Multipurpose For In Vitro Coagulation Studies
24d
Cleared
Sep 30, 1985
LODE COAGULOMETER MODEL LC-6
JPA
System, Multipurpose For In Vitro Coagulation Studies
112d
Cleared
Sep 19, 1985
MSI-HB HEMOGLOBIN CONTROL
JPK
Mixture, Hematology Quality Control
9d
Cleared
Sep 17, 1985
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
GKZ
Counter, Differential Cell
105d
Cleared
Sep 17, 1985
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
GHH
Fibrin Split Products
97d
Cleared
Sep 03, 1985
CELL-DYN BRAND HEMATOLOGY REAGENTS
JPK
Mixture, Hematology Quality Control
91d
Cleared
Aug 30, 1985
COULTER VOLUME ADAPTER
GKL
Counter, Cell, Automated (particle Counter)
119d
Cleared
Aug 29, 1985
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
10d
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