PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS— 510(k) K024182

Name: FDA 510(k) clearance K024182
Creator: U.S. Food and Drug Administration
Published: 2003-03-03

Substantially Equivalent

Precision Systems, Inc.

FDA 510(k) clearance K024182 for PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS, Substantially Equivalent on 2003-03-03. Applicant: Precision Systems, Inc.. Device class: 2.

Clearance details

Applicant: Precision Systems, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 2002-12-19
Decision date: 2003-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

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