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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, Phencyclidine
510(k) Number K041578
Device Name QUICKSCREEN, MODELS 9177X AND 9178X
Applicant
Phamatech
10151 Barnes Canyon Rd.
San Diego,  CA  92121
Applicant Contact CARL MONGIOVI
Correspondent
Phamatech
10151 Barnes Canyon Rd.
San Diego,  CA  92121
Correspondent Contact CARL MONGIOVI
Classification Product Code
LCM  
Subsequent Product Codes
DIO   DJC   DJG   DKZ   LDJ  
Date Received06/14/2004
Decision Date 09/10/2004
Decision Substantially Equivalent (SESE)
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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