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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK051966
Test Name Worldwide Medical First Check Multi Drug Cup 7  (OTC)
Manufacturer NameWorldwide Medical, LLC
Consumer Information Phone Number(888)788-5716
Test TypeMethylenedioxymethamphetamine (MDMA)
Effective Date11/29/2005
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K051966
Device Name FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
Applicant
Worldwide Medical, LLC
13 Spectrum Pointe Dr.
Lake Forest,  CA  92630
Applicant Contact KEVIN J GADAWSKI
Correspondent
Worldwide Medical, LLC
13 Spectrum Pointe Dr.
Lake Forest,  CA  92630
Correspondent Contact KEVIN J GADAWSKI
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJG   LAF   LCM   LDJ  
Date Received07/20/2005
Decision Date 09/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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