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
1417–1440 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 15, 1994
FACTOR VIII DEFICIENT PLASMA
K935057 · GJT
Sigma Diagnostics, Inc.
Hematology · 145d
Cleared Mar 15, 1994
GLYCATED HEMOGLOBIN CONTROLS
K940143 · LCP
Primus Corp.
Hematology · 63d
Cleared Mar 11, 1994
ERYTHROPOIETIN IMMUNOASSAY KIT
K932650 · GGT
Nichols Institute
Hematology · 282d
Cleared Mar 11, 1994
COULTER MULTI Q PREP
K935953 · GKH
Coulter Corp.
Hematology · 88d
Cleared Mar 09, 1994
SE-CHECK
K940181 · JPK
Streck Laboratories, Inc.
Hematology · 56d
Cleared Mar 07, 1994
FACTOR X DEFICIENT PLASMA
K935054 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
FACTOR VII DEFICIENT PLASMA
K935056 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
FACTOR
K935058 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 01, 1994
STAGO FACTOR V-DEFICIENT PLASMA
K934605 · GJT
American Bioproducts Co.
Hematology · 155d
Cleared Mar 01, 1994
STAGO FACTOR II-DEFICIENT PLASMA
K934606 · GJT
American Bioproducts Co.
Hematology · 155d
Cleared Feb 23, 1994
TINTELIZER(R) TPA
K934314 · GGP
Biopool AB
Hematology · 175d
Cleared Feb 22, 1994
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
K924401 · GGC
Behring Diagnostics, Inc.
Hematology · 540d
Cleared Feb 22, 1994
CONTROL PLASMA U
K924402 · GGC
Behring Diagnostics, Inc.
Hematology · 540d
Cleared Feb 22, 1994
CONTROL PLASMA N
K924403 · GIZ
Behring Diagnostics, Inc.
Hematology · 540d
Cleared Feb 07, 1994
IL TEST HEPARIN (XA), PN 84699-15
K935212 · KFF
Instrumentation Laboratory CO
Hematology · 101d
Cleared Feb 03, 1994
FAST'N'FLAMMATORY KIT
K931241 · GIA
Techlab, Inc.
Hematology · 329d
Cleared Jan 27, 1994
HEMOCARD, HEMOGLOBIN C ASSAY
K923153 · MLL
Isolab, Inc.
Hematology · 577d
Cleared Jan 27, 1994
SPECTROLYSE HEPARIN KIT
K923499 · KFF
Biopool AB
Hematology · 561d
Cleared Jan 27, 1994
MDA PROTEIN ASSAY
K925617 · GGP
Organon Teknika Corp.
Hematology · 447d
Cleared Jan 27, 1994
TOA MEDICAL ELECTRONICS CA-5000
K933886 · JPA
Toa Medical Electronics USA, Inc.
Hematology · 170d
Cleared Jan 27, 1994
CENTRIFIQ BLOOD CONTROL
K935343 · JPK
Hematronix, Inc.
Hematology · 128d
Cleared Dec 27, 1993
PARA 4 PLUS
K933844 · JJY
Streck Laboratories, Inc.
Hematology · 143d
Cleared Dec 06, 1993
REFLOTRON HEMOGLOBIN TEST TABS
K934064 · KHG
Boehringer Mannheim Corp.
Hematology · 159d
Cleared Dec 06, 1993
APTT-ES REAGENT
K934351 · GFO
Medical Diagnostic Technologies, Inc.
Hematology · 90d