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 the device name listed in this FDA 510(k) record. The listed applicant is Bioporto Diagnostic, Inc.. It received FDA 510(k) clearance on 2023-12-07 under 510(k) 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. The listed applicant is Bioporto Diagnostic, Inc.. The 510(k) number is K232761.

When did ProNephro AKI™ (NGAL) receive FDA 510(k) clearance?

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

Who is the listed applicant for ProNephro AKI™ (NGAL)?

The FDA 510(k) record lists Bioporto Diagnostic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: PIG)

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.

K210793VIDAS NEPHROCHECKBiomérieux SA K171482NEPHROCHECK Test SystemAstute Medical, Inc.K153165NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) KitAstute Medical, Inc.

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.