URYXXON RELAX URINE ANALYZER— 510(k) K061742

Name: FDA 510(k) clearance K061742
Creator: U.S. Food and Drug Administration
Published: 2006-09-06

Substantially Equivalent

Macherey-Nagel GmbH & Co. KG

FDA 510(k) clearance K061742 for URYXXON RELAX URINE ANALYZER, Substantially Equivalent on 2006-09-06. Applicant: Macherey-Nagel GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Macherey-Nagel GmbH & Co. KG
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2006-06-20
Decision date: 2006-09-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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