Cleared Traditional

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT

K102643 · Astoria-Pacific, Inc. · Chemistry

Jul 2011

Decision

304d

Days

Class 2

Risk

About This 510(k) Submission

K102643 is an FDA 510(k) clearance for the SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT, a Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase (Class II — Special Controls, product code KQP), submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on July 15, 2011, 304 days after receiving the submission on September 14, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1315.

Submission Details

510(k) Number	K102643 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2010
Decision Date	July 15, 2011
Days to Decision	304 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	KQP — Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1315