Tina-quant Cystatin C Gen.2
K-Number: K161817 · 2016-07-27
ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2016-07-27
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Tina-quant Cystatin C Gen.2 is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-07-27 under approval number K161817. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tina-quant Cystatin C Gen.2?
Tina-quant Cystatin C Gen.2 is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K161817.
When was Tina-quant Cystatin C Gen.2 approved by the FDA?
Tina-quant Cystatin C Gen.2 received FDA 510(k) clearance on 2016-07-27, under approval number K161817.
What company makes Tina-quant Cystatin C Gen.2?
Tina-quant Cystatin C Gen.2 is manufactured by Roche Diagnostics Operations (Rdo).
What is the FDA product code for Tina-quant Cystatin C Gen.2?
The FDA product code for Tina-quant Cystatin C Gen.2 is NDY.
Other Devices by Roche Diagnostics Operations (Rdo)
Related Devices (Code: NDY)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.