SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT— 510(k) K102643

Substantially Equivalent

Astoria-Pacific, Inc.

FDA 510(k) clearance K102643 for SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT, Substantially Equivalent on 2011-07-15. Applicant: Astoria-Pacific, Inc..

Clearance details

Applicant: Astoria-Pacific, Inc.
Product code: Code KQP
Advisory panel: Clinical Chemistry
Date received: 2010-09-14
Decision date: 2011-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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