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.
3293
Total
3286
Cleared
158d
Avg (2y)
1976
Since
1855 Hematology devices
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
NEOPLASTINE(R) CI KIT
GJS
Test, Time, Prothrombin
189d
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
Cleared
Dec 01, 1992
CLOTTING FACTOR V DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
92d
Cleared
Dec 01, 1992
NEOTHROMITIN(R)
GPO
Antigen, Cf, Typhus Fever Group
92d
Cleared
Dec 01, 1992
CLIBRATION PLASMAS
GGN
Plasma, Coagulation Control
92d
Cleared
Dec 01, 1992
CONTROL PLASMA P
GGC
Control, Plasma, Abnormal
92d
Cleared
Nov 17, 1992
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
GGM
Control, Hemoglobin
223d
Cleared
Nov 16, 1992
ENZYGNOST F 1+2
MIF
Prothrombin Fragment 1.2
151d
Cleared
Nov 16, 1992
QC-CHEX
JPK
Mixture, Hematology Quality Control
102d
Cleared
Nov 16, 1992
STANDARD HUMAN PLASMA
JPA
System, Multipurpose For In Vitro Coagulation Studies
77d
Cleared
Oct 26, 1992
COAG-CONTROL [N] KIT
GGN
Plasma, Coagulation Control
171d
Cleared
Oct 26, 1992
IL TEST PT FIBRINOGEN HS
GIS
Test, Fibrinogen
82d
Cleared
Oct 19, 1992
PLATELIN L
GFO
Activated Partial Thromboplastin
210d
Cleared
Oct 14, 1992
COULTER MULTI-Q-PREP
GKH
Apparatus, Automated Blood Cell Diluting
90d
Cleared
Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
LCP
Assay, Glycosylated Hemoglobin
166d
Cleared
Sep 25, 1992
HEMOLAB SILIMAT REAGENT
GFI
Osteotome, Manual
267d
Cleared
Sep 23, 1992
NEW STACHROM ANTIPLASMIN
GGP
Test, Qualitative And Quantitative Factor Deficiency
181d
Cleared
Sep 22, 1992
QBC HEMACAN HEMATOLOGY SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
88d
Cleared
Sep 22, 1992
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
KQJ
System, Fibrinogen Determination
64d
Cleared
Sep 11, 1992
TECHNICON H*2
GKZ
Counter, Differential Cell
71d
Cleared
Sep 11, 1992
TRACE ALBUMIN-MR REAGENT
CIX
Bromcresol Green Dye-binding, Albumin
66d
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