K-number	K193053
Device name	Tina-quant Hemoglobin A1cDx Gen.3
Applicant	Roche Diagnostics Operations (Rdo)
Product code	PDJ
Device class	Class II
Decision date	Mar 26, 2020
Decision	Substantially Equivalent
Regulation	862.1373

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View the full FDA submission: accessdata.fda.gov

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Tina-quant Hemoglobin A1cDx Gen.3

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