NEPHROCHECK Test System— 510(k) K171482

Substantially Equivalent

Astute Medical, Inc.

FDA 510(k) clearance K171482 for NEPHROCHECK Test System, Substantially Equivalent on 2017-11-16. 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: 2017-05-19
Decision date: 2017-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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