Cleared Traditional

CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL

K962768 · Coulter Corp. · Hematology
Jan 1997
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K962768 is an FDA 510(k) clearance for the CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on January 6, 1997, 203 days after receiving the submission on June 17, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K962768 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1996
Decision Date January 06, 1997
Days to Decision 203 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220