SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT— 510(k) K121101

Substantially Equivalent

Astoria-Pacific, Inc.

FDA 510(k) clearance K121101 for SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT, Substantially Equivalent on 2013-06-20. Applicant: Astoria-Pacific, Inc..

Clearance details

Applicant: Astoria-Pacific, Inc.
Product code: Code JIA
Advisory panel: Clinical Chemistry
Date received: 2012-04-11
Decision date: 2013-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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