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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 K981687
Device Name QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
Applicant
Phamatech
9265 Activity Rd., #112-113
San Diego,  CA  92126
Applicant Contact CARL A MONGIOVI
Correspondent
Phamatech
9265 Activity Rd., #112-113
San Diego,  CA  92126
Correspondent Contact CARL A MONGIOVI
Regulation Number862.3170
Classification Product Code
JXM  
Date Received05/13/1998
Decision Date 06/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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