RUBELLA ANTIGEN AND CONTROL ANTIGEN— 510(k) K894262

Name: FDA 510(k) clearance K894262
Creator: U.S. Food and Drug Administration
Published: 1989-10-16

Substantially Equivalent

Microbix Biosystems, Inc.

FDA 510(k) clearance K894262 for RUBELLA ANTIGEN AND CONTROL ANTIGEN, Substantially Equivalent on 1989-10-16. Applicant: Microbix Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Microbix Biosystems, Inc.
Product code: Code GON
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1989-06-21
Decision date: 1989-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flemington, NJ, US

Download summary PDF View on FDA.gov ↗

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