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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, Cocaine And Cocaine Metabolites
510(k) Number K010833
Device Name AT WORK DRUG TEST, MODEL 9177T AWT
Applicant
Phamatech
9530 Padgett St., #101
San Diego,  CA  92126
Applicant Contact CARL A MONGIOVI
Correspondent
Phamatech
9530 Padgett St., #101
San Diego,  CA  92126
Correspondent Contact CARL A MONGIOVI
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   DKZ   LAF   LCL   LDJ  
MVO  
Date Received03/20/2001
Decision Date 04/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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