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
2065–2088 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 16, 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315 · JBQ
Baxter Healthcare Corp
Hematology · 50d
Cleared Mar 09, 1988
COULTER CLONE T11 MONOCLONAL ANTIBODY
K875047 · GKZ
Coulter Electronics, Inc.
Hematology · 92d
Cleared Mar 09, 1988
HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
K875089 · JPA
Hemotec, Inc.
Hematology · 91d
Cleared Mar 01, 1988
MSI-DIFF PLUS
K880270 · JPK
Medical Specialties, Inc.
Hematology · 40d
Cleared Feb 24, 1988
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
K875102 · JPD
Bio-Rad
Hematology · 76d
Cleared Feb 19, 1988
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.
K874838 · GKZ
Coulter Electronics, Inc.
Hematology · 87d
Cleared Feb 19, 1988
FACTOR VIII REFERENCE PLASMA
K880292 · GJT
Helena Laboratories
Hematology · 25d
Cleared Feb 19, 1988
CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
K880302 · GGN
Hemotec, Inc.
Hematology · 25d
Cleared Feb 18, 1988
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
K874763 · GKZ
Instrumentation Laboratory CO
Hematology · 91d
Cleared Feb 17, 1988
UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM
K875354 · LCP
Ulster Scientific, Inc.
Hematology · 48d
Cleared Feb 16, 1988
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
K874328 · JCF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 117d
Cleared Feb 11, 1988
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
K875062 · GJS
Em Diagnostic Systems, Inc.
Hematology · 64d
Cleared Feb 09, 1988
CALIBRATION REFERENCE PLASMA
K874940 · GGP
Baxter Healthcare Corp
Hematology · 69d
Cleared Feb 09, 1988
FIBRINOSTICON
K880077 · GHH
Organon Teknika Corp.
Hematology · 29d
Cleared Feb 04, 1988
HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12
K874429 · GIQ
Hf Scientific, Inc.
Hematology · 99d
Cleared Feb 04, 1988
THROMBOPLASTIN.C
K874592 · GJS
Baxter Healthcare Corp
Hematology · 87d
Cleared Jan 27, 1988
CELLECT LABTRAK SOFTWARE
K874320 · GKL
Instrumentation Laboratory CO
Hematology · 98d
Cleared Jan 19, 1988
COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA
K874188 · GKM
Coulter Electronics, Inc.
Hematology · 97d
Cleared Jan 12, 1988
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
K875061 · GIO
Sherwood Medical Co.
Hematology · 34d
Cleared Jan 11, 1988
QBC BLOOD BANK SYSTEM
K874147 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 90d
Cleared Jan 05, 1988
CELL COUNTING GRID GRATICULE
K874190 · IBJ
Portable Medical Laboratories, Inc.
Hematology · 83d
Cleared Jan 05, 1988
PT PRO-CLOT
K874373 · JBR
Probe-Tek, Inc.
Hematology · 71d
Cleared Jan 05, 1988
QBC SYSTEM HEMOGLOBIN
K874427 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 69d
Cleared Jan 05, 1988
FLUID SAMPLING PACK
K874436 · KSS
U.S. Mfg. & Management, Inc.
Hematology · 69d