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
Feb 05, 1993
BIOVATION K-MANAGER
GKZ
Counter, Differential Cell
95d
Cleared
Feb 05, 1993
SPUNCRIT
GKG
Centrifuge, Hematocrit
78d
Cleared
Feb 03, 1993
BIOMERIEUX HEMOLAB THROMBOMAT
GJS
Test, Time, Prothrombin
93d
Cleared
Jan 28, 1993
POWER SUPPLY
JJN
Apparatus, Electrophoresis, For Clinical Use
170d
Cleared
Jan 27, 1993
HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
GFO
Activated Partial Thromboplastin
148d
Cleared
Jan 21, 1993
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
177d
Cleared
Jan 21, 1993
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
GKZ
Counter, Differential Cell
91d
Cleared
Jan 14, 1993
HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT
GFO
Activated Partial Thromboplastin
135d
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
Jan 11, 1993
DADE HEPZYME
JBR
Test, Heparin Neutralization
75d
Cleared
Jan 07, 1993
MSI-HCT
GLK
Control, Hematocrit
99d
Cleared
Dec 29, 1992
CD4 CYTOSPHERES KIT
GKZ
Counter, Differential Cell
287d
Cleared
Dec 23, 1992
STACLOT LA TEST KIT
GFO
Activated Partial Thromboplastin
149d
Cleared
Dec 21, 1992
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
JPA
System, Multipurpose For In Vitro Coagulation Studies
108d
Cleared
Dec 18, 1992
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
JPA
System, Multipurpose For In Vitro Coagulation Studies
107d
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 07, 1992
COAMATE PROTEIN C CHROMOGENIC ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
210d
Cleared
Dec 07, 1992
NEOPLASTINE(R) CI KIT
GJS
Test, Time, Prothrombin
189d
Cleared
Dec 03, 1992
FIAGEN PROGESTERONE
JLS
Radioimmunoassay, Progesterone
146d
Cleared
Dec 03, 1992
BICARBONATE
KHS
Enzymatic, Carbon-dioxide
76d
Cleared
Dec 01, 1992
BEHRING FIBRINTIMER A
JPA
System, Multipurpose For In Vitro Coagulation Studies
106d
Cleared
Dec 01, 1992
HEMOCARD(TM) CONTROL
JCM
Control, Hemoglobin, Abnormal
104d
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