Cleared Traditional

URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)

K970277 · Astoria-Pacific, Inc. · Chemistry

Dec 1997

Decision

322d

Days

Class 2

Risk

About This 510(k) Submission

K970277 is an FDA 510(k) clearance for the URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K), 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 December 11, 1997, 322 days after receiving the submission on January 23, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1315.

Submission Details

510(k) Number	K970277 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 1997
Decision Date	December 11, 1997
Days to Decision	322 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