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FDA 510(k)

NEPHROCHECK Test System

K-Number: K171482 · 2017-11-16

ApplicantAstute Medical, Inc.
Decision Date2017-11-16
Product CodePIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEPHROCHECK Test System is a medical device manufactured by Astute Medical, Inc.. It received FDA 510(k) clearance on 2017-11-16 under approval number K171482. 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 NEPHROCHECK Test System?

NEPHROCHECK Test System is a medical device that received FDA 510(k) clearance on 2017-11-16. It is manufactured by Astute Medical, Inc.. The 510(k) number is K171482.

When was NEPHROCHECK Test System approved by the FDA?

NEPHROCHECK Test System received FDA 510(k) clearance on 2017-11-16, under approval number K171482.

What company makes NEPHROCHECK Test System?

NEPHROCHECK Test System is manufactured by Astute Medical, Inc..

What is the FDA product code for NEPHROCHECK Test System?

The FDA product code for NEPHROCHECK Test System is PIG.

Other Devices by Astute Medical, Inc.

K153165NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

Related Devices (Code: PIG)

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