Cleared Traditional

CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1

K922744 · Coulter Immunology · Hematology
Feb 1993
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K922744 is an FDA 510(k) clearance for the CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on February 5, 1993, 242 days after receiving the submission on June 8, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K922744 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1992
Decision Date February 05, 1993
Days to Decision 242 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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