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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 K060355
Device Name ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
Applicant
Acro Biotech, LLC
9500 7th St. Unit M
Rancho Cucamonga,  CA  91730 -9094
Applicant Contact GREGORY LEE
Correspondent
Acro Biotech, LLC
9500 7th St. Unit M
Rancho Cucamonga,  CA  91730 -9094
Correspondent Contact GREGORY LEE
Regulation Number862.3610
Classification Product Code
DJC  
Date Received02/13/2006
Decision Date 08/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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