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FDA 510(k)

Tina-quant Transferrin ver.2 (urine application)

K-Number: K182095 · 2018-11-05

ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2018-11-05
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Tina-quant Transferrin ver.2 (urine application) is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2018-11-05 under approval number K182095. The device is classified under product code DDG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tina-quant Transferrin ver.2 (urine application)?

Tina-quant Transferrin ver.2 (urine application) is a medical device that received FDA 510(k) clearance on 2018-11-05. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K182095.

When was Tina-quant Transferrin ver.2 (urine application) approved by the FDA?

Tina-quant Transferrin ver.2 (urine application) received FDA 510(k) clearance on 2018-11-05, under approval number K182095.

What company makes Tina-quant Transferrin ver.2 (urine application)?

Tina-quant Transferrin ver.2 (urine application) is manufactured by Roche Diagnostics Operations (Rdo).

What is the FDA product code for Tina-quant Transferrin ver.2 (urine application)?

The FDA product code for Tina-quant Transferrin ver.2 (urine application) is DDG.

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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.

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