Cleared Traditional

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS

K024182 · Precision Systems, Inc. · Chemistry

Mar 2003

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K024182 is an FDA 510(k) clearance for the PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Precision Systems, Inc. (Natick, US). The FDA issued a Cleared decision on March 3, 2003, 74 days after receiving the submission on December 19, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number	K024182 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2002
Decision Date	March 03, 2003
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF