Cleared Traditional

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER

K013654 · Precision Systems, Inc. · Toxicology

Jun 2002

Decision

211d

Days

Class 1

Risk

About This 510(k) Submission

K013654 is an FDA 510(k) clearance for the PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by Precision Systems, Inc. (Natick, US). The FDA issued a Cleared decision on June 5, 2002, 211 days after receiving the submission on November 6, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number	K013654 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2001
Decision Date	June 05, 2002
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF