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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometry, Morphine
510(k) Number K013124
Device Name MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
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 Number862.3640
Classification Product Code
DJJ  
Subsequent Product Codes
DIO   DKZ  
Date Received09/19/2001
Decision Date 11/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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