MYCOPLASMA SPP SEROLOGICAL REAGENTS— 510(k) K852933

Name: FDA 510(k) clearance K852933
Creator: U.S. Food and Drug Administration
Published: 1985-08-01

Substantially Equivalent

Microbix Biosystems, Inc.

FDA 510(k) clearance K852933 for MYCOPLASMA SPP SEROLOGICAL REAGENTS, Substantially Equivalent on 1985-08-01. Applicant: Microbix Biosystems, Inc.. Device class: 1.

Clearance details

Applicant: Microbix Biosystems, Inc.
Product code: Code GSB
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1985-07-09
Decision date: 1985-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

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