ALERE PBP2A TEST— 510(k) K121905

Substantially Equivalent

Alere Scarborough, Inc.

FDA 510(k) clearance K121905 for ALERE PBP2A TEST, Substantially Equivalent on 2012-07-26. Applicant: Alere Scarborough, Inc..

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: Code MYI
Advisory panel: Microbiology
Date received: 2012-06-29
Decision date: 2012-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Scarborough, ME, US

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