Cleared Special

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup

K162395 · Mp Biomedicals, LLC · Toxicology
Jun 2017
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K162395 is an FDA 510(k) clearance for the MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Mp Biomedicals, LLC (Burlingame, US). The FDA issued a Cleared decision on June 2, 2017, 280 days after receiving the submission on August 26, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K162395 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2016
Decision Date June 02, 2017
Days to Decision 280 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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