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.
3292
Total
3285
Cleared
161d
Avg (2y)
1976
Since
773 Hematology devices
Cleared
Oct 04, 1993
IL TEST (TM) PT-FIBRINOGEN HS PLUS
GJS
Test, Time, Prothrombin
94d
Cleared
Aug 23, 1993
CASCADE M, CAT. NO. 1710
GKP
Instrument, Coagulation, Automated
125d
Cleared
Aug 16, 1993
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
JBD
System, Analysis, Electrophoretic Hemoglobin
144d
Cleared
Aug 13, 1993
IL TEST FIBRINOGEN-C
KQJ
System, Fibrinogen Determination
128d
Cleared
Aug 09, 1993
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
LGS
Fluorescence Polarization Immunoassay, Theophylline
98d
Cleared
Aug 05, 1993
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
190d
Cleared
Jul 14, 1993
ABBOTT ENCOUNTER(TM)Q
GKZ
Counter, Differential Cell
174d
Cleared
Jul 06, 1993
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
JBD
System, Analysis, Electrophoretic Hemoglobin
104d
Cleared
Jun 18, 1993
IL MCL-2 COAGULATION ANALYZER
GKP
Instrument, Coagulation, Automated
309d
Cleared
Jun 02, 1993
VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
GGJ
Fluid, Diluting, White-cell
161d
Cleared
Apr 12, 1993
IL TEST(TM) PROTEIN S
GGP
Test, Qualitative And Quantitative Factor Deficiency
80d
Cleared
Mar 29, 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
LCP
Assay, Glycosylated Hemoglobin
91d
Cleared
Mar 11, 1993
VARIANT BETA-THALASSEMIA SHORT PROGRAM
JPD
Hemoglobin A2 Quantitation
209d
Cleared
Feb 12, 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
JPA
System, Multipurpose For In Vitro Coagulation Studies
64d
Cleared
Feb 05, 1993
SPUNCRIT
GKG
Centrifuge, Hematocrit
78d
Cleared
Jan 14, 1993
VARIANT SICKLE CELL SHORT PROGRAM
GKA
Abnormal Hemoglobin Quantitation
111d
Cleared
Jan 14, 1993
IL TEST(TM) PRO-CHROM
GGP
Test, Qualitative And Quantitative Factor Deficiency
108d
Cleared
Jan 12, 1993
BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
LCP
Assay, Glycosylated Hemoglobin
98d
Cleared
Dec 18, 1992
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479
JJY
Multi-analyte Controls, All Kinds (assayed)
80d
Cleared
Dec 15, 1992
LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
JCF
Lymphocyte Separation Medium
608d
Cleared
Dec 03, 1992
BICARBONATE
KHS
Enzymatic, Carbon-dioxide
76d
Cleared
Oct 26, 1992
IL TEST PT FIBRINOGEN HS
GIS
Test, Fibrinogen
82d
Cleared
Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
LCP
Assay, Glycosylated Hemoglobin
166d
Cleared
Sep 22, 1992
QBC HEMACAN HEMATOLOGY SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
88d
Cleared
Aug 25, 1992
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
JPD
Hemoglobin A2 Quantitation
49d
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