AB FLU OIA— 510(k) K981651

Substantially Equivalent

Biostar, Inc.

FDA 510(k) clearance K981651 for AB FLU OIA, Substantially Equivalent on 1998-11-25. Applicant: Biostar, Inc.. Device class: 2.

Clearance details

Applicant: Biostar, Inc.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 1998-05-11
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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