Cleared Traditional

CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1

K964618 · Coulter Corp. · Hematology
Dec 1996
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K964618 is an FDA 510(k) clearance for the CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Maimi, US). The FDA issued a Cleared decision on December 23, 1996, 69 days after receiving the submission on October 15, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K964618 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1996
Decision Date December 23, 1996
Days to Decision 69 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