TOTAL PROTEIN URINE/CSF GEN.3— 510(k) K071239

Name: FDA 510(k) clearance K071239
Creator: U.S. Food and Drug Administration
Published: 2007-09-14

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K071239 for TOTAL PROTEIN URINE/CSF GEN.3, Substantially Equivalent on 2007-09-14. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JGQ
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 2007-05-03
Decision date: 2007-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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