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 02, 1994
COATEST(R) ANTITHROMBIN III, MODIFICATION
JBQ
Antithrombin Iii Quantitation
419d
Cleared
May 02, 1994
SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
138d
Cleared
Apr 26, 1994
GLYCATED PROTEIN CONTROLS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
105d
Cleared
Apr 25, 1994
CD8 CYTOSPHERES KIT
MAM
Dna-probe, B And T Lymphocyte
627d
Cleared
Apr 21, 1994
FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
DAT
Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
569d
Cleared
Apr 21, 1994
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
GJA
Test, Thrombin Time
535d
Cleared
Apr 21, 1994
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
GGT
Assay, Erythropoietin
378d
Cleared
Apr 20, 1994
HELENA THROMBOPLASTIN-MI REAGENT
GJS
Test, Time, Prothrombin
86d
Cleared
Apr 19, 1994
BERICHROM ANTITHROMBIN III (A)
JPE
Antithrombin Iii, Two Stage Clotting Time Assay
295d
Cleared
Apr 19, 1994
MULTIFIBREN U
KQJ
System, Fibrinogen Determination
228d
Cleared
Apr 05, 1994
PARA 5 DIFF
JPK
Mixture, Hematology Quality Control
161d
Cleared
Apr 05, 1994
RADIAS MONOCLONAL HBA 1C ASSAY
LCP
Assay, Glycosylated Hemoglobin
134d
Cleared
Mar 31, 1994
HBM HEMOGLOBINOMETER
GIG
Hemoglobinometer
238d
Cleared
Mar 30, 1994
ASSESS(TM) LOW ABNORMAL CONTROL
GJS
Test, Time, Prothrombin
391d
Cleared
Mar 30, 1994
ASSESS(TM) HIGH ABNORMAL CONTROL
GJS
Test, Time, Prothrombin
391d
Cleared
Mar 22, 1994
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
GGC
Control, Plasma, Abnormal
427d
Cleared
Mar 22, 1994
COAGULATION A.R.P.
GGN
Plasma, Coagulation Control
264d
Cleared
Mar 22, 1994
GLYCATED HEMOGLOBIN CALIBRATORS
LCP
Assay, Glycosylated Hemoglobin
83d
Cleared
Mar 22, 1994
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
JPK
Mixture, Hematology Quality Control
74d
Cleared
Mar 15, 1994
FACTOR VIII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
145d
Cleared
Mar 15, 1994
GLYCATED HEMOGLOBIN CONTROLS
LCP
Assay, Glycosylated Hemoglobin
63d
Cleared
Mar 11, 1994
ERYTHROPOIETIN IMMUNOASSAY KIT
GGT
Assay, Erythropoietin
282d
Cleared
Mar 11, 1994
COULTER MULTI Q PREP
GKH
Apparatus, Automated Blood Cell Diluting
88d
Cleared
Mar 09, 1994
SE-CHECK
JPK
Mixture, Hematology Quality Control
56d
Cleared
Mar 07, 1994
FACTOR X DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
137d
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices