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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, Amphetamine
510(k) Number K001397
Device Name QUICKSCREEN PRO DRUG CUP, MODEL 9195X
Applicant
Phamatech
9265 Activity Rd., #112-113
San Diego,  CA  92126
Applicant Contact CARL MONGIOVI
Correspondent
Phamatech
9265 Activity Rd., #112-113
San Diego,  CA  92126
Correspondent Contact CARL MONGIOVI
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJG   DJR   JXM  
LAF   LCM   LDJ  
Date Received05/03/2000
Decision Date 05/26/2000
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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