Cleared Traditional

SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT

K121101 · Astoria-Pacific, Inc. · Chemistry
Jun 2013
Decision
435d
Days
Class 1
Risk

About This 510(k) Submission

K121101 is an FDA 510(k) clearance for the SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT, a Enzymatic Methods, Galactose (Class I — General Controls, product code JIA), submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on June 20, 2013, 435 days after receiving the submission on April 11, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1310.

Submission Details

510(k) Number K121101 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2012
Decision Date June 20, 2013
Days to Decision 435 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIA — Enzymatic Methods, Galactose
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1310

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