Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Hematology ×
3,297 results
1441–1464 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
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
Cleared Dec 06, 1993
CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
K934497 · JCN
R&D Systems, Inc.
Hematology · 83d
Cleared Dec 06, 1993
SPECTROLYSE FACTOR VII:C
K934584 · GGP
Meditech, Inc.
Hematology · 74d
Cleared Dec 03, 1993
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
K934747 · JPA
R & D Batteries, Inc.
Hematology · 60d
Cleared Nov 29, 1993
BATROXOBIN REAGENT
K932787 · JCO
Behring Diagnostics, Inc.
Hematology · 173d
Cleared Nov 22, 1993
TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
K933475 · GKZ
Miles, Inc.
Hematology · 129d
Cleared Nov 22, 1993
TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
K933478 · GKZ
Miles, Inc.
Hematology · 129d
Cleared Nov 15, 1993
TAS ANALYZER
K933092 · GKP
Cardiovascular Diagnostic Services
Hematology · 144d
Cleared Nov 15, 1993
STAGO FACTOR IX-DEFICIENT PLASMA
K933432 · GJT
American Bioproducts Co.
Hematology · 124d
Cleared Nov 05, 1993
GLYCOHEMOGLOBIN
K931183 · LCP
Teco Diagnostics
Hematology · 241d
Cleared Nov 05, 1993
NEW STACHROM PROTEIN C TEST KIT
K931906 · GGP
American Bioproducts Co.
Hematology · 206d
Cleared Nov 03, 1993
FDP - SLIDEX DIRECT
K921989 · GHH
Biomerieux Vitek, Inc.
Hematology · 554d
Cleared Nov 03, 1993
CA-1000 AUTOMATED COAGULATION ANALYZER
K931149 · JPA
Toa Medical Electronics USA, Inc.
Hematology · 240d
Cleared Nov 02, 1993
AGGRO/LINK CONTROL SOFTWARE
K932566 · JBX
Chrono-Log Corp.
Hematology · 159d
Cleared Nov 02, 1993
FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
K932657 · DAP
More Diagnostics
Hematology · 153d
Cleared Oct 27, 1993
STAGO FACTOR XII-DEFICIENT PLASMA
K933438 · GJT
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR VII-DEFICIENT PLASMA
K933440 · GJT
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR X-DEFICIENT PLASMA
K933441 · GJT
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR XI-DEFICIENT PLASMA
K933444 · GJT
American Bioproducts Co.
Hematology · 105d
Cleared Oct 25, 1993
PATHROMTIN
K932011 · GFO
Behring Diagnostics, Inc.
Hematology · 185d
Cleared Oct 18, 1993
COAGULATION REFERENCE PLASMA, NORMAL
K932145 · GIZ
American Diagnostic Corp.
Hematology · 167d
Cleared Oct 04, 1993
IL TEST (TM) PT-FIBRINOGEN HS PLUS
K933252 · GJS
Instrumentation Laboratory CO
Hematology · 94d