Cleared Traditional

MYCOPLASMA SPP SEROLOGICAL REAGENTS

K852933 · Microbix Biosystems, Inc. · Microbiology
Aug 1985
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K852933 is an FDA 510(k) clearance for the MYCOPLASMA SPP SEROLOGICAL REAGENTS, a Antigens, Cf, All, Mycoplasma Spp. (Class I — General Controls, product code GSB), submitted by Microbix Biosystems, Inc. (Canada, CA). The FDA issued a Cleared decision on August 1, 1985, 23 days after receiving the submission on July 9, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number K852933 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1985
Decision Date August 01, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GSB — Antigens, Cf, All, Mycoplasma Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3375