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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Methamphetamine
510(k) Number K972556
Device Name QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
Applicant
Phamatech
9265 Activity Rd.
Suite 112-113
Sandiego,  CA  92126
Applicant Contact TUAN H PHAM
Correspondent
Phamatech
9265 Activity Rd.
Suite 112-113
Sandiego,  CA  92126
Correspondent Contact TUAN H PHAM
Regulation Number862.3610
Classification Product Code
LAF  
Date Received07/09/1997
Decision Date 09/02/1997
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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