Cleared Traditional

TOXCUP DRUG SCREEN CUP

K122633 · Branan Medical Corp. · Chemistry
Feb 2013
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K122633 is an FDA 510(k) clearance for the TOXCUP DRUG SCREEN CUP, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on February 7, 2013, 162 days after receiving the submission on August 29, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K122633 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2012
Decision Date February 07, 2013
Days to Decision 162 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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