Cleared Traditional

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT

K080294 · Astoria-Pacific, Inc. · Chemistry
Nov 2008
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K080294 is an FDA 510(k) clearance for the ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT, a System, Test, Biotinidase (Class II — Special Controls, product code NAK), submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on November 4, 2008, 274 days after receiving the submission on February 4, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1118.

Submission Details

510(k) Number K080294 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2008
Decision Date November 04, 2008
Days to Decision 274 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NAK — System, Test, Biotinidase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1118