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
Apr 30, 1996
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
GKZ
Counter, Differential Cell
211d
Cleared
Apr 26, 1996
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
GKA
Abnormal Hemoglobin Quantitation
157d
Cleared
Apr 25, 1996
NOVA CO-OXIMETER ANALYZER
GLY
Oximeter To Measure Hemoglobin
176d
Cleared
Apr 23, 1996
SYNTHAFAX APTT REAGENT
GFO
Activated Partial Thromboplastin
134d
Cleared
Apr 19, 1996
PATHROMTIN SL
GFO
Activated Partial Thromboplastin
142d
Cleared
Apr 03, 1996
VENOM TIEM REAGENT
JCO
Bothrops Atrox Reagent
146d
Cleared
Apr 03, 1996
CALIBRATION VERIFICATION ASSESSMENT (CVA)
JPK
Mixture, Hematology Quality Control
54d
Cleared
Mar 28, 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
GKZ
Counter, Differential Cell
90d
Cleared
Mar 13, 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
86d
Cleared
Mar 12, 1996
KC 1A COAGULATION ANALYZER/SET
JPA
System, Multipurpose For In Vitro Coagulation Studies
85d
Cleared
Mar 11, 1996
PORCINE FACTOR VIII
GGN
Plasma, Coagulation Control
298d
Cleared
Mar 11, 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
84d
Cleared
Mar 01, 1996
RNA MEDICAL HEMAT CONTROL
JJR
Electrolyte Controls (assayed And Unassayed)
81d
Cleared
Feb 29, 1996
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
GGP
Test, Qualitative And Quantitative Factor Deficiency
297d
Cleared
Feb 29, 1996
FLOW-COUNT COULTER FLUOROSPHERES
GKZ
Counter, Differential Cell
141d
Cleared
Feb 29, 1996
BIOCLOT PROTEIN S
GGP
Test, Qualitative And Quantitative Factor Deficiency
76d
Cleared
Feb 29, 1996
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
KRX
Calibrator For Cell Indices
69d
Cleared
Feb 14, 1996
CHROM Z-HEPARIN, CAT. NO 5242
KFF
Assay, Heparin
247d
Cleared
Feb 09, 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
LCP
Assay, Glycosylated Hemoglobin
266d
Cleared
Feb 09, 1996
CHROM Z-F:VIII, CAT. NO. 5241
GGP
Test, Qualitative And Quantitative Factor Deficiency
242d
Cleared
Feb 08, 1996
COULTER LINEARITY CONTROL
JPK
Mixture, Hematology Quality Control
80d
Cleared
Jan 31, 1996
AT-III CONTROL PLASMA KIT
GGC
Control, Plasma, Abnormal
89d
Cleared
Jan 30, 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
GGP
Test, Qualitative And Quantitative Factor Deficiency
232d
Cleared
Jan 30, 1996
4C PLUS COULTER CELL CONTROL
JPK
Mixture, Hematology Quality Control
89d
Cleared
Jan 26, 1996
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/
GKZ
Counter, Differential Cell
458d
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices