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

Name: FDA 510(k) clearance K121101
Creator: U.S. Food and Drug Administration
Published: 2013-06-20

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.. Device class: 1.

Clearance details

Applicant: Astoria-Pacific, Inc.
Product code: Code JIA
Device class: Class 1
Regulation: 21 CFR 862.1310
Advisory panel: Clinical Chemistry
Date received: 2012-04-11
Decision date: 2013-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

Download summary PDF View on FDA.gov ↗

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