Stat Profile Prime Plus Analyzer System— 510(k) K200204

Name: FDA 510(k) clearance K200204
Creator: U.S. Food and Drug Administration
Published: 2020-04-06

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K200204 for Stat Profile Prime Plus Analyzer System, Substantially Equivalent on 2020-04-06. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code GGZ
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 2020-01-28
Decision date: 2020-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

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