NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit— 510(k) K153165

Name: FDA 510(k) clearance K153165
Creator: U.S. Food and Drug Administration
Published: 2016-06-01

Substantially Equivalent

Astute Medical, Inc.

FDA 510(k) clearance K153165 for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit, Substantially Equivalent on 2016-06-01. Applicant: Astute Medical, Inc.. Device class: 2.

Clearance details

Applicant: Astute Medical, Inc.
Product code: Code PIG
Device class: Class 2
Regulation: 21 CFR 862.1220
Advisory panel: Clinical Chemistry
Date received: 2015-11-02
Decision date: 2016-06-01
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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