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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
510(k) Number K002418
Device Name BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
Applicant
Branan Medical Corporation
10015 Muirlands Rd., Suite E
Irvine,  CA  92618
Applicant Contact RAPHAEL WONG
Correspondent
Branan Medical Corporation
10015 Muirlands Rd., Suite E
Irvine,  CA  92618
Correspondent Contact RAPHAEL WONG
Regulation Number862.3640
Classification Product Code
DOE  
Date Received08/08/2000
Decision Date 11/22/2000
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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