Cleared Traditional

COULTER CLONE T8 MONOCLONAL ANTIBODY

K893853 · Coulter Immunology · Hematology
Mar 1990
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K893853 is an FDA 510(k) clearance for the COULTER CLONE T8 MONOCLONAL ANTIBODY, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on March 2, 1990, 281 days after receiving the submission on May 25, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K893853 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 1989
Decision Date March 02, 1990
Days to Decision 281 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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