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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Tricyclic Antidepressant Drugs
510(k) Number K010734
Device Name BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
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 Number862.3910
Classification Product Code
MLK  
Date Received03/12/2001
Decision Date 07/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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