Cleared Traditional

NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D

K101392 · Astoria-Pacific, Inc. · Chemistry

Feb 2011

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K101392 is an FDA 510(k) clearance for the NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D, 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 February 4, 2011, 262 days after receiving the submission on May 18, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1315.

Submission Details

510(k) Number	K101392 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2010
Decision Date	February 04, 2011
Days to Decision	262 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