Nova StatSensor Creatinine Hospital Meter System— 510(k) K171059

Name: FDA 510(k) clearance K171059
Creator: U.S. Food and Drug Administration
Published: 2017-05-26

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K171059 for Nova StatSensor Creatinine Hospital Meter System, Substantially Equivalent on 2017-05-26. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code CGL
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2017-04-10
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

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