MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup— 510(k) K162395

Name: FDA 510(k) clearance K162395
Creator: U.S. Food and Drug Administration
Published: 2017-06-02

Substantially Equivalent

Mp Biomedicals, LLC

FDA 510(k) clearance K162395 for MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup, Substantially Equivalent on 2017-06-02. Applicant: Mp Biomedicals, LLC. Device class: 2.

Clearance details

Applicant: Mp Biomedicals, LLC
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2016-08-26
Decision date: 2017-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

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