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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, Opiates
510(k) Number K043051
Device Name QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
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 Number862.3650
Classification Product Code
DJG  
Date Received11/04/2004
Decision Date 02/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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