BD MAX Check-Points CPO— 510(k) K190613

Name: FDA 510(k) clearance K190613
Creator: U.S. Food and Drug Administration
Published: 2019-08-29

Substantially Equivalent

Check-Points Health B.V.

FDA 510(k) clearance K190613 for BD MAX Check-Points CPO, Substantially Equivalent on 2019-08-29. Applicant: Check-Points Health B.V.. Device class: 2.

Clearance details

Applicant: Check-Points Health B.V.
Product code: Code POC
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2019-03-11
Decision date: 2019-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wageningen, NL

Download summary PDF View on FDA.gov ↗

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