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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, benzodiazepine
510(k) Number K002342
Device Name BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
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 Number862.3170
Classification Product Code
JXM  
Date Received08/01/2000
Decision Date 11/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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