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
Jul 10, 2006
CELL-DYN RUBY SYSTEM
GKZ
Counter, Differential Cell
26d
Cleared
Jul 06, 2006
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
GKZ
Counter, Differential Cell
72d
Cleared
Jun 30, 2006
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
JBD
System, Analysis, Electrophoretic Hemoglobin
190d
Cleared
Jun 27, 2006
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
GKA
Abnormal Hemoglobin Quantitation
308d
Cleared
Jun 08, 2006
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
GKR
System, Hemoglobin, Automated
55d
Cleared
Jun 06, 2006
BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166
GKZ
Counter, Differential Cell
113d
Cleared
Jun 06, 2006
HEMA SCREEN SPECIFIC IFOBT
KHE
Reagent, Occult Blood
104d
Cleared
Jun 02, 2006
R&D LH-NRBC HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
22d
Cleared
May 24, 2006
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
KFF
Assay, Heparin
464d
Cleared
May 17, 2006
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
JPK
Mixture, Hematology Quality Control
30d
Cleared
May 10, 2006
CRYOCHECK CLOT APCR
GGW
Test, Time, Partial Thromboplastin
96d
Cleared
May 10, 2006
SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
GKZ
Counter, Differential Cell
58d
Cleared
May 10, 2006
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
JPA
System, Multipurpose For In Vitro Coagulation Studies
27d
Cleared
May 04, 2006
STA-CEPHASCREEN KIT
GFO
Activated Partial Thromboplastin
181d
Cleared
May 04, 2006
INSURE II
KHE
Reagent, Occult Blood
29d
Cleared
May 02, 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
GJS
Test, Time, Prothrombin
27d
Cleared
Apr 14, 2006
GUAVA EZCD4 SYSTEM
GKZ
Counter, Differential Cell
120d
Cleared
Apr 13, 2006
HEMOSIL SYNTHASIL
GFO
Activated Partial Thromboplastin
29d
Cleared
Mar 28, 2006
COULTER 5C CELL CONTROL
JPK
Mixture, Hematology Quality Control
34d
Cleared
Mar 16, 2006
IMMOCARE
KHE
Reagent, Occult Blood
176d
Cleared
Mar 08, 2006
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
GKA
Abnormal Hemoglobin Quantitation
355d
Cleared
Feb 21, 2006
ACL ELITE
JPA
System, Multipurpose For In Vitro Coagulation Studies
29d
Cleared
Feb 09, 2006
NRBC-CHEX FOR LH
GJR
Control, Red-cell
29d
Cleared
Jan 24, 2006
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
JOY
Device, Automated Cell-locating
127d
Cleared
Jan 20, 2006
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
GGP
Test, Qualitative And Quantitative Factor Deficiency
107d
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