Cleared Traditional

CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT

K950742 · Coulter Corp. · Hematology
Aug 1995
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K950742 is an FDA 510(k) clearance for the CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on August 25, 1995, 189 days after receiving the submission on February 17, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K950742 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1995
Decision Date August 25, 1995
Days to Decision 189 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