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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 a medical device manufactured by Biomérieux SA. It received FDA 510(k) clearance on 2022-07-08 under approval 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. It is manufactured by Biomérieux SA. The 510(k) number is K210793.

When was VIDAS NEPHROCHECK approved by the FDA?

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

What company makes VIDAS NEPHROCHECK?

VIDAS NEPHROCHECK is manufactured by Biomérieux SA.

What is the FDA product code for VIDAS NEPHROCHECK?

The FDA product code for VIDAS NEPHROCHECK is PIG.

Other Devices by Biomérieux SA

K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

Related Devices (Code: PIG)

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