COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY— 510(k) K121610

Name: FDA 510(k) clearance K121610
Creator: U.S. Food and Drug Administration
Published: 2013-08-08

Substantially Equivalent

Roche Diagnostics Operations

FDA 510(k) clearance K121610 for COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY, Substantially Equivalent on 2013-08-08. Applicant: Roche Diagnostics Operations. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Operations
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2012-06-01
Decision date: 2013-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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