FLU OIA A/B TEST KIT— 510(k) K023556

Substantially Equivalent

Thermo Biostar, Inc.

FDA 510(k) clearance K023556 for FLU OIA A/B TEST KIT, Substantially Equivalent on 2003-03-27. Applicant: Thermo Biostar, Inc.. Device class: 2.

Clearance details

Applicant: Thermo Biostar, Inc.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2002-10-23
Decision date: 2003-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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