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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme immunoassay, propoxyphene
510(k) Number K122752
Device Name FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD
Original Applicant
BRANAN MEDICAL CORP.
140 technology dr ste 400
irvine,  CA  92618
Original Contact olivia chan
Regulation Number862.3700
Classification Product Code
JXN  
Date Received09/07/2012
Decision Date 01/30/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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