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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, Barbiturate
510(k) Number K070009
Device Name AT HOME DRUG TEST MODELS, 9308T AND 9308X
Applicant
Phamatech, Inc.
10151 Barnes Canyon Rd.
San Diego,  CA  92121
Applicant Contact CARL MONGIOVI
Correspondent
Phamatech, Inc.
10151 Barnes Canyon Rd.
San Diego,  CA  92121
Correspondent Contact CARL MONGIOVI
Regulation Number862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DJG   DJR   JXM  
Date Received01/03/2007
Decision Date 12/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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