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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, Amphetamine
510(k) Number K004034
Device Name MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
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 Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJC   DJG   DOE   LDJ  
Date Received12/28/2000
Decision Date 03/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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