PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS— 510(k) K022072

Name: FDA 510(k) clearance K022072
Creator: U.S. Food and Drug Administration
Published: 2002-08-23

Substantially Equivalent

Precision Systems, Inc.

FDA 510(k) clearance K022072 for PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS, Substantially Equivalent on 2002-08-23. Applicant: Precision Systems, Inc.. Device class: 2.

Clearance details

Applicant: Precision Systems, Inc.
Product code: Code CIX
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 2002-06-26
Decision date: 2002-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

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