Cleared Traditional

FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD

K122752 · Branan Medical Corp. · Toxicology
Jan 2013
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K122752 is an FDA 510(k) clearance for the FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD, a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on January 30, 2013, 145 days after receiving the submission on September 7, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number K122752 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2012
Decision Date January 30, 2013
Days to Decision 145 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXN — Enzyme Immunoassay, Propoxyphene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3700

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