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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 a medical device manufactured by Astute Medical, Inc.. It received FDA 510(k) clearance on 2016-06-01 under approval 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. It is manufactured by Astute Medical, Inc.. The 510(k) number is K153165.

When was NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit approved by the FDA?

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 approval number K153165.

What company makes 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 manufactured by Astute Medical, Inc..

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.

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Other Devices by Astute Medical, Inc.

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Related Devices (Code: PIG)

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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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