cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay— 510(k) K160571

Name: FDA 510(k) clearance K160571
Creator: U.S. Food and Drug Administration
Published: 2016-12-19

Substantially Equivalent

Roche Diagnostics Operations (Rdo)

FDA 510(k) clearance K160571 for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay, Substantially Equivalent on 2016-12-19. Applicant: Roche Diagnostics Operations (Rdo). Device class: 2.

Clearance details

Applicant: Roche Diagnostics Operations (Rdo)
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2016-02-29
Decision date: 2016-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K160571

K-number listed on FDA's recall record

Z-2478-2019 — cobas c513 AnalyzerClass II·Terminated·Roche Diagnostics Operations, Inc.·20190718

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160571.

Data sourced from openFDA. This site is unofficial and independent of the FDA.