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FDA 510(k)

VIDAS NEPHROCHECK

K-Number: K210793 · 2022-07-08

ApplicantBiomérieux SA
Decision Date2022-07-08
Product CodePIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIDAS NEPHROCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux SA. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K210793. 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 VIDAS NEPHROCHECK?

VIDAS NEPHROCHECK is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Biomérieux SA. The 510(k) number is K210793.

When did VIDAS NEPHROCHECK receive FDA 510(k) clearance?

VIDAS NEPHROCHECK received FDA 510(k) clearance on 2022-07-08, under 510(k) number K210793.

Who is the listed applicant for VIDAS NEPHROCHECK?

The FDA 510(k) record lists Biomérieux SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIDAS NEPHROCHECK?

The FDA product code for VIDAS NEPHROCHECK is PIG.

Other records listing Biomérieux SA as applicant

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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.

K232761ProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc.K171482NEPHROCHECK Test SystemAstute Medical, Inc.K153165NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) KitAstute Medical, 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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