CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS— 510(k) K080459

Name: FDA 510(k) clearance K080459
Creator: U.S. Food and Drug Administration
Published: 2009-11-17

Substantially Equivalent

Chromsystems Instruments & Chemicals GmbH

FDA 510(k) clearance K080459 for CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS, Substantially Equivalent on 2009-11-17. Applicant: Chromsystems Instruments & Chemicals GmbH. Device class: 1.

Clearance details

Applicant: Chromsystems Instruments & Chemicals GmbH
Product code: Code LAS
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 2008-02-20
Decision date: 2009-11-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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