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

51 results for "Coulter Corp."
1–24 of 51
Search insights Median review: 83d Cleared: 100% Top manufacturer: Coulter Corp. Lead specialty: Hematology
Cleared Apr 20, 2000
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
K993356 · GKZ
Coulter Corp.
Hematology · 197d
Cleared May 11, 1999
COULTER Z2 ANALYZER
K991070 · GKL
Coulter Corp.
Hematology · 41d
Cleared Apr 26, 1999
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
K990327 · GKZ
Coulter Corp.
Hematology · 83d
Cleared Apr 13, 1999
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT...
K990172 · GKZ
Coulter Corp.
Hematology · 84d
Cleared Apr 01, 1999
COULTER AC T DIFF 2 ANALYZER
K990352 · GKZ
Coulter Corp.
Hematology · 55d
Cleared Mar 16, 1999
IMMUNO-TROL CONTROL CELLS
K984216 · JPK
Coulter Corp.
Hematology · 112d
Cleared Nov 09, 1998
CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K982167 · GKZ
Coulter Corp.
Hematology · 143d
Cleared Nov 05, 1998
CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K982166 · GKZ
Coulter Corp.
Hematology · 139d
Cleared Sep 24, 1998
CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH...
K982172 · GKZ
Coulter Corp.
Hematology · 97d
Cleared Oct 29, 1997
COULTER AC.T DIFF ANALYZER
K973634 · GKZ
Coulter Corp.
Hematology · 35d
Cleared Jun 30, 1997
COULTER ACT TRON CELL CONTROL
K971469 · JPK
Coulter Corp.
Hematology · 69d
Cleared Mar 06, 1997
COULTER AC.T SERIES ANALYZER
K964988 · GKZ
Coulter Corp.
Hematology · 83d
Cleared Jan 22, 1997
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT...
K963263 · GKZ
Coulter Corp.
Hematology · 155d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT...
K962768 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K962305 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Dec 23, 1996
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH...
K964618 · GKZ
Coulter Corp.
Hematology · 69d
Cleared Oct 30, 1996
COULTER GEN-S SYSTEM
K962988 · GKL
Coulter Corp.
Hematology · 90d
Cleared Jul 22, 1996
COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
K961278 · GKZ
Coulter Corp.
Hematology · 110d
Cleared Feb 29, 1996
FLOW-COUNT COULTER FLUOROSPHERES
K954688 · GKZ
Coulter Corp.
Hematology · 141d
Cleared Feb 08, 1996
COULTER LINEARITY CONTROL
K955334 · JPK
Coulter Corp.
Hematology · 80d
Cleared Jan 30, 1996
4C PLUS COULTER CELL CONTROL
K955016 · JPK
Coulter Corp.
Hematology · 89d
Cleared Oct 06, 1995
COULTER Z 1
K952308 · GKL
Coulter Corp.
Hematology · 142d
Cleared Aug 25, 1995
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
K950742 · GKZ
Coulter Corp.
Hematology · 189d
Cleared Jul 20, 1995
COULTER MH025A
K950949 · GKZ
Coulter Corp.
Hematology · 140d