COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET— 510(k) K141143

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K141143 for COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET, Substantially Equivalent on 2014-07-17. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code NDY
Advisory panel: Clinical Chemistry
Date received: 2014-05-02
Decision date: 2014-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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