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
1177–1200 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 05, 1996
TAS A PTT TEST CONTROLS
K961189 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 71d
Cleared May 30, 1996
BEHRING COAGULATION TIMER
K955278 · GGN
Behring Diagnostics, Inc.
Hematology · 195d
Cleared May 30, 1996
TAS HMT CONTROLS
K960234 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 134d
Cleared May 29, 1996
ERYTHROPOIETIN IMMUNOASSAY KIT
K952559 · GGT
Nichols Institute
Hematology · 362d
Cleared May 24, 1996
CD-CHEX + RBC
K960894 · GGL
Streck Laboratories, Inc.
Hematology · 80d
Cleared May 24, 1996
LA POSITIVE CONTROL PLASMA
K961370 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared May 22, 1996
MICRO21 WITH ANA
K960774 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 86d
Cleared May 20, 1996
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955673 · GKZ
Abbott Laboratories
Hematology · 196d
Cleared May 17, 1996
MICRO21 WITH RETIC
K960776 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 81d
Cleared May 17, 1996
QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
K960827 · GKZ
Becton Dickinson Diagnostic...
Hematology · 78d
Cleared May 17, 1996
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL,...
K960887 · GKZ
Dako Corp.
Hematology · 74d
Cleared May 13, 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
K950568 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 460d
Cleared May 13, 1996
ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950625 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 458d
Cleared May 13, 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
K951100 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 430d
Cleared May 13, 1996
WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
K953116 · GKZ
Intl. Remote Imaging Systems
Hematology · 315d
Cleared May 10, 1996
ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950482 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 462d
Cleared May 09, 1996
ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY...
K935720 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 891d
Cleared May 02, 1996
ABBOTT CELL-DYN 3500R SYSTEM
K960427 · GKZ
Sequoia Turner Corp.
Hematology · 94d
Cleared Apr 30, 1996
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
K954570 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 211d
Cleared Apr 26, 1996
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · GKA
Bio-Rad
Hematology · 157d
Cleared Apr 25, 1996
NOVA CO-OXIMETER ANALYZER
K955013 · GLY
Nova Biomedical Corp.
Hematology · 176d
Cleared Apr 23, 1996
SYNTHAFAX APTT REAGENT
K955638 · GFO
Ortho Diagnostic Systems, Inc.
Hematology · 134d
Cleared Apr 19, 1996
PATHROMTIN SL
K955450 · GFO
Behring Diagnostics, Inc.
Hematology · 142d
Cleared Apr 03, 1996
VENOM TIEM REAGENT
K955115 · JCO
Medical Diagnostic Technologies, Inc.
Hematology · 146d