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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, Amphetamine
510(k) Number K130082
Device Name GENPRIME DRUGS OF ABUSE READER SYSTEM
Applicant
Genprime, Inc.
1983 Hazelwood Rd.
Oms River,  NJ  08753
Applicant Contact Maureen Garner
Correspondent
Genprime, Inc.
1983 Hazelwood Rd.
Oms River,  NJ  08753
Correspondent Contact Maureen Garner
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DNK   JQT   LCM   LDJ  
Date Received01/14/2013
Decision Date 12/20/2013
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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