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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 K043167
Device Name PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
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 Number862.3170
Classification Product Code
JXM  
Date Received11/16/2004
Decision Date 12/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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