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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Methamphetamine
510(k) Number K053033
Device Name ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
Applicant
Acro Biotech, LLC
9500 7th St. Unit M
Rancho Cucamonga,  CA  91730
Applicant Contact GREGORY LEE
Correspondent
Acro Biotech, LLC
9500 7th St. Unit M
Rancho Cucamonga,  CA  91730
Correspondent Contact GREGORY LEE
Regulation Number862.3610
Classification Product Code
DJC  
Date Received10/27/2005
Decision Date 06/06/2006
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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