TOTAL PROTEIN URINE/CSF GEN.3— 510(k) K141925

Substantially Equivalent

Roche Diagnostics Operations (Rdo)

FDA 510(k) clearance K141925 for TOTAL PROTEIN URINE/CSF GEN.3, Substantially Equivalent on 2014-12-09. Applicant: Roche Diagnostics Operations (Rdo).

Clearance details

Applicant: Roche Diagnostics Operations (Rdo)
Product code: Code JIQ
Advisory panel: Clinical Chemistry
Date received: 2014-07-16
Decision date: 2014-12-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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