ACTIM PROM— 510(k) K123986

Substantially Equivalent

Alere Scarborough, Inc.

FDA 510(k) clearance K123986 for ACTIM PROM, Substantially Equivalent on 2014-01-09. Applicant: Alere Scarborough, Inc..

Clearance details

Applicant: Alere Scarborough, Inc.
Product code: Code OAM
Advisory panel: Clinical Chemistry
Date received: 2012-12-26
Decision date: 2014-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

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