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FDA 510(k)

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

K-Number: K153165 · 2016-06-01

ApplicantAstute Medical, Inc.
Decision Date2016-06-01
Product CodePIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit is the device name listed in this FDA 510(k) record. The listed applicant is Astute Medical, Inc.. It received FDA 510(k) clearance on 2016-06-01 under 510(k) number K153165. 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 Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit?

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit is a medical device that received FDA 510(k) clearance on 2016-06-01. The listed applicant is Astute Medical, Inc.. The 510(k) number is K153165.

When did NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit receive FDA 510(k) clearance?

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit received FDA 510(k) clearance on 2016-06-01, under 510(k) number K153165.

Who is the listed applicant for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit?

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

What is the FDA product code for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit?

The FDA product code for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit is PIG.

Other records listing Astute Medical, Inc. as applicant

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.

K171482NEPHROCHECK Test System

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.K210793VIDAS NEPHROCHECKBiomérieux SAK171482NEPHROCHECK Test SystemAstute 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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