Cleared Traditional

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

K010844 · Astoria-Pacific, Inc. · Chemistry

Sep 2001

Decision

184d

Days

Class 2

Risk

About This 510(k) Submission

K010844 is an FDA 510(k) clearance for the ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K, a System, Test, Biotinidase (Class II — Special Controls, product code NAK), submitted by Astoria-Pacific, Inc. (Clakamas, US). The FDA issued a Cleared decision on September 21, 2001, 184 days after receiving the submission on March 21, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1118.

Submission Details

510(k) Number	K010844 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2001
Decision Date	September 21, 2001
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF