PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER— 510(k) K013654

Name: FDA 510(k) clearance K013654
Creator: U.S. Food and Drug Administration
Published: 2002-06-05

Substantially Equivalent

Precision Systems, Inc.

FDA 510(k) clearance K013654 for PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER, Substantially Equivalent on 2002-06-05. Applicant: Precision Systems, Inc.. Device class: 1.

Clearance details

Applicant: Precision Systems, Inc.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 2001-11-06
Decision date: 2002-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

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