Cleared Traditional

MONOCLONAL ANTIBODY ANTI-CD3

K901189 · Sigma Chemical Co. · Hematology
Oct 1991
Decision
597d
Days
Class 2
Risk

About This 510(k) Submission

K901189 is an FDA 510(k) clearance for the MONOCLONAL ANTIBODY ANTI-CD3, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on October 31, 1991, 597 days after receiving the submission on March 13, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K901189 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 1990
Decision Date October 31, 1991
Days to Decision 597 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