ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT— 510(k) K080294

Name: FDA 510(k) clearance K080294
Creator: U.S. Food and Drug Administration
Published: 2008-11-04

Substantially Equivalent

Astoria-Pacific, Inc.

FDA 510(k) clearance K080294 for ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT, Substantially Equivalent on 2008-11-04. Applicant: Astoria-Pacific, Inc.. Device class: 2.

Clearance details

Applicant: Astoria-Pacific, Inc.
Product code: Code NAK
Device class: Class 2
Regulation: 21 CFR 862.1118
Advisory panel: Clinical Chemistry
Date received: 2008-02-04
Decision date: 2008-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

Download summary PDF View on FDA.gov ↗

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