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
Dec 08, 2003
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
KSR
Container, Empty, For Collection & Processing Of Blood & Blood Components
89d
Cleared
Dec 08, 2003
POTENS +
JPA
System, Multipurpose For In Vitro Coagulation Studies
69d
Cleared
Nov 24, 2003
IMMUNICON CELLTRACKS ANALYZER
GKZ
Counter, Differential Cell
301d
Cleared
Nov 24, 2003
HBA SPERM-HYALURONAN BINDING ASSAY
POV
Semen Analysis Device
70d
Cleared
Nov 03, 2003
CRYOCHECK WEAK LUPUS POSITIVE CONTROL
GGC
Control, Plasma, Abnormal
55d
Cleared
Oct 24, 2003
QUANTEX D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
80d
Cleared
Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
GKR
System, Hemoglobin, Automated
73d
Cleared
Sep 26, 2003
COULTER LH 750 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
59d
Cleared
Sep 24, 2003
HEMAPROMPT GASTRIC
KHE
Reagent, Occult Blood
166d
Cleared
Sep 24, 2003
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
GKR
System, Hemoglobin, Automated
97d
Cleared
Sep 17, 2003
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
GGN
Plasma, Coagulation Control
23d
Cleared
Sep 08, 2003
I-STAT KAOLIN ACT TEST
JBP
Activated Whole Blood Clotting Time
319d
Cleared
Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
GKP
Instrument, Coagulation, Automated
130d
Cleared
Sep 08, 2003
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
69d
Cleared
Sep 08, 2003
ADVIA 60 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
24d
Cleared
Sep 02, 2003
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
214d
Cleared
Aug 25, 2003
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
GKR
System, Hemoglobin, Automated
38d
Cleared
Aug 20, 2003
DUET SYSTEM
JOY
Device, Automated Cell-locating
211d
Cleared
Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
64d
Cleared
Aug 08, 2003
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
GGN
Plasma, Coagulation Control
39d
Cleared
Jul 31, 2003
HEMOSIL FACTOR IX DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
48d
Cleared
Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
24d
Cleared
Jul 03, 2003
GENERAL SEMEN ANALYSIS (GSA) KIT
POV
Semen Analysis Device
188d
Cleared
Jul 02, 2003
SECQUIRE CELL SEPARATOR
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
204d
Cleared
Jul 02, 2003
MICROHEATER
BSB
Warmer, Blood, Non-electromagnetic Radiation
51d
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