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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 K030113
Device Name MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
Applicant
Branan Medical Corp.
10015 Muirlands Rd., Suite E
Irvine,  CA  92618
Applicant Contact RAPHAEL WONG
Correspondent
Branan Medical Corp.
10015 Muirlands Rd., Suite E
Irvine,  CA  92618
Correspondent Contact RAPHAEL WONG
Regulation Number862.3650
Classification Product Code
DJG  
Date Received01/13/2003
Decision Date 07/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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