FDA 510(k)

ProNephro AKI (NGAL)

K-Number: K232761 · 2023-12-07

Decision Date2023-12-07

Product CodePIG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ProNephro AKI (NGAL) is a medical device manufactured by Bioporto Diagnostic, Inc.. It received FDA 510(k) clearance on 2023-12-07 under approval number K232761. The device is classified under product code PIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProNephro AKI (NGAL)?

ProNephro AKI (NGAL) is a medical device that received FDA 510(k) clearance on 2023-12-07. It is manufactured by Bioporto Diagnostic, Inc.. The 510(k) number is K232761.

When was ProNephro AKI (NGAL) approved by the FDA?

ProNephro AKI (NGAL) received FDA 510(k) clearance on 2023-12-07, under approval number K232761.

What company makes ProNephro AKI (NGAL)?

ProNephro AKI (NGAL) is manufactured by Bioporto Diagnostic, Inc..

What is the FDA product code for ProNephro AKI (NGAL)?

The FDA product code for ProNephro AKI (NGAL) is PIG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.