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
1417–1440 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 22, 1994
COAGULATION A.R.P.
K933277 · GGN
Helena Laboratories
Hematology · 264d
Cleared Mar 22, 1994
GLYCATED HEMOGLOBIN CALIBRATORS
K936204 · LCP
Primus Corp.
Hematology · 83d
Cleared Mar 22, 1994
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
K940089 · JPK
R&D Systems, Inc.
Hematology · 74d
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