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
1297–1320 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 25, 1995
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
K950742 · GKZ
Coulter Corp.
Hematology · 189d
Cleared Aug 24, 1995
FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
K946193 · GIL
More Diagnostics
Hematology · 247d
Cleared Aug 24, 1995
FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
K946265 · GIL
Clinical Controls, Inc.
Hematology · 244d
Cleared Aug 22, 1995
TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP
K950057 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 229d
Cleared Aug 14, 1995
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
K952789 · GKZ
Immunotech Corp.
Hematology · 56d
Cleared Aug 07, 1995
COATEST(R) APC(TM) RESISTANCE
K945940 · GGW
Axis-Shield Doc AS
Hematology · 245d
Cleared Jul 24, 1995
ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
K951071 · KRZ
Alko Diagnostic Corp.
Hematology · 138d
Cleared Jul 20, 1995
COULTER MH025A
K950949 · GKZ
Coulter Corp.
Hematology · 140d
Cleared Jul 13, 1995
BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES
K942087 · GGP
Biopool AB
Hematology · 437d
Cleared Jul 05, 1995
OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES
K952182 · GKZ
Immunotech, Inc.
Hematology · 57d
Cleared Jun 29, 1995
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
K933934 · JBF
Sigma Diagnostics, Inc.
Hematology · 687d
Cleared Jun 20, 1995
CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES
K944126 · GKZ
Caltag Laboratories, Inc.
Hematology · 301d
Cleared Jun 20, 1995
CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY
K944127 · GKZ
Caltag Laboratories, Inc.
Hematology · 301d
Cleared Jun 20, 1995
CALTAG CD4 R-PE MONOCLONAL ANTIBODY
K944128 · GKZ
Caltag Laboratories, Inc.
Hematology · 301d
Cleared Jun 15, 1995
MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS
K943571 · DAP
More Diagnostics
Hematology · 331d
Cleared Jun 09, 1995
ABBOTT VISION GLYCATED HB, MODIFICATION
K936285 · LCP
Abbott Laboratories
Hematology · 526d
Cleared Jun 09, 1995
SYSMEX(TM) F-820, 520
K945837 · GKZ
Sysmex Corp.
Hematology · 192d
Cleared May 23, 1995
THE STACHROM HEPARIN ASSAY KIT
K925433 · KFF
American Bioproducts Co.
Hematology · 937d
Cleared May 19, 1995
BIOMERIEUX HEMOLAB COFAC II
K942049 · GJT
Biomerieux Vitek, Inc.
Hematology · 386d
Cleared May 19, 1995
HEMOLAB COFAC IX
K942050 · GJT
Biomerieux Vitek, Inc.
Hematology · 386d
Cleared May 15, 1995
TRAX(TM) CD4 TEST KIT
K925255 · GKZ
T Cell Diagnostics, Inc.
Hematology · 938d
Cleared May 11, 1995
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
K940209 · GGN
Ortho Diagnostic Systems, Inc.
Hematology · 482d
Cleared May 11, 1995
COAGUCHEK SYSTEM
K942884 · GJS
Boehringer Mannheim Corp.
Hematology · 328d
Cleared May 11, 1995
STACLOT HEPARIN TEST KIT
K943517 · KFF
American Bioproducts Co.
Hematology · 294d