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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 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 2018-11-05 under 510(k) 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. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K182095.

When did Tina-quant Transferrin ver.2 (urine application) receive FDA 510(k) clearance?

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

Who is the listed applicant for Tina-quant Transferrin ver.2 (urine application)?

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

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

Other records listing Roche Diagnostics Operations (Rdo) as applicant

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Related Devices (Code: DDG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240987Access sTfRBeckman Coulter, Inc.K190495TransferrinBiosystems S.A.

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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