FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
3241–3264 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Feb 28, 1977
HEMATRAK MATURITY PROFILE OPTION
K761208 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 83d
Cleared Feb 28, 1977
PLATELET CONTROL, NORMAL & ABNORMAL
K770095 · JPK
Bd Becton Dickinson Vacutainer...
Hematology · 42d
Cleared Feb 18, 1977
HPC TM (HEPARINIZED PLASMA CONTROL)
K770188 · GGC
Bio/Data Corp.
Hematology · 21d
Cleared Feb 16, 1977
PLATELET-CHEX-HUMAN
K770020 · JPK
Streck Laboratories, Inc.
Hematology · 41d
Cleared Feb 16, 1977
COUNTER, BLOOD CELL & HEMATOCRIT
K770034 · GKL
Mallinckrodt Critical Care
Hematology · 37d
Cleared Feb 14, 1977
BLOOD/FLUID WARMER MODEL DW-1000A
K770232 · BSB
Gorman Rupp Industries
Hematology · 7d
Cleared Feb 08, 1977
CAMCO R PAK-GUAIAC
K770153 · KHE
Cambridge Chemical Products, Inc.
Hematology · 15d
Cleared Feb 07, 1977
QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
K761058 · GGP
Bio/Data Corp.
Hematology · 81d
Cleared Feb 07, 1977
MICROSAMPLE BLOOD COLLECTION DEVICE
K761137 · GKH
Ortho Diagnostics, Inc.
Hematology · 75d
Cleared Feb 01, 1977
TPC-LYOPHILIZED POOLED HUMAN PLASMA
K761091 · JPA
Bio/Data Corp.
Hematology · 71d
Cleared Feb 01, 1977
JTB 700 HEMATOLOGY ANALYZER
K761304 · JPJ
J.T. Baker Chemical Co.
Hematology · 41d
Cleared Jan 17, 1977
TERASAKI LYMPHOCYTE TRANSPORT KIT
K760952 · KSR
Dravon Medical, Inc.
Hematology · 76d
Cleared Jan 12, 1977
AGGRECETIN
K760893 · JOZ
Bio/Data Corp.
Hematology · 77d
Cleared Jan 10, 1977
BLOOD CELL PROCESSOR MODEL 2 IBM 2991
K760856 · GKT
Intl. Business Machines
Hematology · 87d
Cleared Jan 10, 1977
HEPARIN CONTROL PLASMA
K760918 · GFO
Hyland Therapeutic Div., Travenol...
Hematology · 74d
Cleared Jan 10, 1977
BARBITAL SALINE BUFFER
K761170 · JCE
Bio/Data Corp.
Hematology · 40d
Cleared Jan 10, 1977
VERONAL BUFFER
K761171 · JPA
Bio/Data Corp.
Hematology · 40d
Cleared Jan 10, 1977
TRIS BUFFERED SALINE
K761172 · JPA
Bio/Data Corp.
Hematology · 40d
Cleared Jan 10, 1977
TRIS BUFFERED
K761173 · JPA
Bio/Data Corp.
Hematology · 40d
Cleared Jan 10, 1977
PHYSIOLOGIC SALINE (0.85%)
K761174 · JCE
Bio/Data Corp.
Hematology · 40d
Cleared Jan 10, 1977
IMIDAZOLE BUFFER (0.05M)
K761175 · JPA
Bio/Data Corp.
Hematology · 40d
Cleared Jan 10, 1977
CALCIUM CHLORIDE (0.025M)
K761176 · JPA
Bio/Data Corp.
Hematology · 40d
Cleared Jan 10, 1977
SODIUM CITRATE
K761177 · GJE
Bio/Data Corp.
Hematology · 40d
Cleared Dec 30, 1976
WHOLE BLOOD PLATELET COUNTER -2510
K760765 · GKL
Clay Adams, Div. Becton Dickinson & Co.
Hematology · 87d