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FDA 510(k)

Transferrin

K-Number: K190495 · 2020-03-16

ApplicantBiosystems S.A.
Decision Date2020-03-16
Product CodeDDG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Transferrin is a medical device manufactured by Biosystems S.A.. It received FDA 510(k) clearance on 2020-03-16 under approval number K190495. 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 Transferrin?

Transferrin is a medical device that received FDA 510(k) clearance on 2020-03-16. It is manufactured by Biosystems S.A.. The 510(k) number is K190495.

When was Transferrin approved by the FDA?

Transferrin received FDA 510(k) clearance on 2020-03-16, under approval number K190495.

What company makes Transferrin?

Transferrin is manufactured by Biosystems S.A..

What is the FDA product code for Transferrin?

The FDA product code for Transferrin is DDG.

Other Devices by Biosystems S.A.

K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL K192730CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

Related Devices (Code: DDG)

K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo) K240987Access sTfRBeckman Coulter, Inc.

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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