BINAXNOX STAPHYLOCOCCUS AUREUS TEST— 510(k) K090964

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K090964 for BINAXNOX STAPHYLOCOCCUS AUREUS TEST, Substantially Equivalent on 2009-12-16. Applicant: Binax, Inc..

Clearance details

Applicant: Binax, Inc.
Product code: Code JWX
Advisory panel: Microbiology
Date received: 2009-04-06
Decision date: 2009-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

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