Cleared Traditional

MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT

K852932 · Microbix Biosystems, Inc. · Immunology

Nov 1985

Decision

126d

Days

Class 1

Risk

About This 510(k) Submission

K852932 is an FDA 510(k) clearance for the MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT, a Antiserum, Cf, Rubeola (Class I — General Controls, product code GRF), submitted by Microbix Biosystems, Inc. (Canada, CA). The FDA issued a Cleared decision on November 12, 1985, 126 days after receiving the submission on July 9, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3520.

Submission Details

510(k) Number	K852932 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 1985
Decision Date	November 12, 1985
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—