FDA 510(k)

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

Número K: K160571 · 2016-12-19

RequerenteRoche Diagnostics Operations (Rdo)

Data da decisão2016-12-19

Código do produtoPDJ

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K160571. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K160571.

When did cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay receive FDA 510(k) clearance?

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay received FDA 510(k) clearance on 2016-12-19, under 510(k) number K160571.

Who is the listed applicant for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

The FDA product code for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is PDJ.

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