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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, opiates
510(k) Number K082508
Device Name FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
Applicant
BRANAN MEDICAL CORPORATION
140 TECHNOLOGY DRIVE
SUITE 400
IRVINE,  CA  92618
Applicant Contact RAPHAEL WONG
Correspondent
BRANAN MEDICAL CORPORATION
140 TECHNOLOGY DRIVE
SUITE 400
IRVINE,  CA  92618
Correspondent Contact RAPHAEL WONG
Regulation Number862.3650
Classification Product Code
DJG  
Date Received08/29/2008
Decision Date 11/21/2008
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
Recalls CDRH Recalls
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