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."
25–48 of 51
Search insights Median review: 83d Cleared: 100% Top manufacturer: Coulter Corp. Lead specialty: Hematology
Cleared Mar 06, 1995
ONYX
K943967 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Dec 08, 1994
COULTER FLOW SET
K944751 · JPK
Coulter Corp.
Hematology · 73d
Cleared Mar 11, 1994
COULTER MULTI Q PREP
K935953 · GKH
Coulter Corp.
Hematology · 88d
Cleared Aug 23, 1993
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
K932030 · GKZ
Coulter Corp.
Hematology · 118d
Cleared Aug 23, 1993
COULTER MH015 (DIFFERENTIAL CELL COUNTER)
K930913 · GKZ
Coulter Corp.
Hematology · 182d
Cleared Jul 06, 1993
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
K926124 · GKZ
Coulter Corp.
Hematology · 214d
Cleared Jan 21, 1993
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
K925344 · GKZ
Coulter Corp.
Hematology · 91d
Cleared Sep 23, 1992
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421 · JZG
Coulter Corp.
Immunology · 72d
Cleared Nov 27, 1991
COULTER CARBON DIOXIDE REAGENT
K914486 · KHS
Coulter Corp.
Chemistry · 50d
Cleared Jul 31, 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174 · LBR
Coulter Corp.
Chemistry · 78d
Cleared Jun 28, 1990
COULTER CREATININE REAGENT
K902172 · CGX
Coulter Corp.
Chemistry · 45d
Cleared Jun 12, 1990
COULTER CARBON DIOXIDE REAGENT
K902229 · KHS
Coulter Corp.
Chemistry · 26d
Cleared Jun 12, 1990
COULTER DIRECT BILIRUBIN
K902199 · CIG
Coulter Corp.
Chemistry · 27d
Cleared Jun 12, 1990
COULTER UREA NITROGEN REAGENT
K902175 · CDQ
Coulter Corp.
Chemistry · 29d
Cleared Jun 12, 1990
COULTER SERUM IRON/UIBC REAGENT
K902173 · JIY
Coulter Corp.
Chemistry · 29d
Cleared May 30, 1990
COULTER ALBUMIN REAGENT
K901268 · CIX
Coulter Corp.
Chemistry · 75d
Cleared May 23, 1990
COULTER CK (CREATINE KINASE) REAGENT
K901267 · CGS
Coulter Corp.
Chemistry · 68d
Cleared Apr 25, 1990
COULTER TOTAL BILIRUBIN REAGENT
K901266 · CIG
Coulter Corp.
Chemistry · 40d
Cleared Apr 16, 1990
COULTER GAMMA-GT (GGT) REAGENT
K901264 · JQB
Coulter Corp.
Chemistry · 31d
Cleared Apr 03, 1990
COULTER CALCIUM REAGENT
K900231 · CJY
Coulter Corp.
Chemistry · 76d
Cleared Apr 03, 1990
COULTER AMYLASE REAGENT
K900230 · JFJ
Coulter Corp.
Chemistry · 76d
Cleared Mar 30, 1990
COULTER JT3
K896873 · GKZ
Coulter Corp.
Hematology · 112d
Cleared Mar 29, 1990
COULTER MAGNESIUM REAGENT
K901265 · JGJ
Coulter Corp.
Chemistry · 13d
Cleared Feb 08, 1990
COULTER ALP (ALK PHOS) REAGENT
K900216 · CJE
Coulter Corp.
Chemistry · 22d