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
Oct 11, 1994
TINA-QUANT HEMOGLOBIN A1C
LCP
Assay, Glycosylated Hemoglobin
417d
Cleared
Oct 07, 1994
SPECIALTY ASSAYED CONTROL-1
GIZ
Plasma, Control, Normal
183d
Cleared
Oct 07, 1994
CBC-LINE HEMATOLOGY LINEARITY CONTROL
JPK
Mixture, Hematology Quality Control
114d
Cleared
Sep 30, 1994
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS
GKZ
Counter, Differential Cell
711d
Cleared
Sep 20, 1994
MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
GKN
Timer, Clot, Automated
232d
Cleared
Sep 20, 1994
AURATEK FDP
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
48d
Cleared
Sep 19, 1994
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
GIZ
Plasma, Control, Normal
322d
Cleared
Sep 14, 1994
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
GGN
Plasma, Coagulation Control
152d
Cleared
Sep 14, 1994
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
LCP
Assay, Glycosylated Hemoglobin
142d
Cleared
Sep 09, 1994
FASCOUNT SYSTME
GKZ
Counter, Differential Cell
417d
Cleared
Sep 08, 1994
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
GIL
Plasma, Fibrinogen Control
342d
Cleared
Aug 30, 1994
SEMEN ANALYSIS KIT
POV
Semen Analysis Device
1014d
Cleared
Aug 30, 1994
ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
GIS
Test, Fibrinogen
182d
Cleared
Jul 19, 1994
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
GGT
Assay, Erythropoietin
215d
Cleared
Jul 19, 1994
ACT CONTROL SET
JPA
System, Multipurpose For In Vitro Coagulation Studies
146d
Cleared
Jul 19, 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
LCP
Assay, Glycosylated Hemoglobin
139d
Cleared
Jun 30, 1994
CATALOG NO. J-ACT+ & QC-ACT+
JBP
Activated Whole Blood Clotting Time
121d
Cleared
Jun 16, 1994
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
JCN
Control, Cell Counter, Normal And Abnormal
42d
Cleared
Jun 06, 1994
CD-CHEX CD4 LOW
GGL
Control, White-cell
426d
Cleared
May 18, 1994
MICROCOAGULATION PROTHROMBIN TIME TEST
GJS
Test, Time, Prothrombin
107d
Cleared
May 17, 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
JBQ
Antithrombin Iii Quantitation
196d
Cleared
May 11, 1994
JR. MICROCOAGULATION SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
104d
Cleared
May 09, 1994
GLYCATED PROTEIN CALIBRATORS
JIS
Calibrator, Primary
125d
Cleared
May 06, 1994
HEMOLAB HEPARICHROM ASSAY
KFF
Assay, Heparin
248d
Cleared
May 04, 1994
ANTITHROMBIN III CHROMOGENIC ASSAY
JBQ
Antithrombin Iii Quantitation
126d
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