Name: Predicase
Price: 199 USD

K-number	K160571
Device name	cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
Applicant	Roche Diagnostics Operations (Rdo)
Product code	PDJ
Device class	Class II
Decision date	Dec 19, 2016
Decision	Substantially Equivalent
Regulation	862.1373

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Source

View the full FDA submission: accessdata.fda.gov

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

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