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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, Cocaine And Cocaine Metabolites
510(k) Number K141647
Device Name HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
Applicant
Healgen Scientific,, LLC
504 E. Diamnond Ave. Suite F
Gaithersburg,  MD  20877
Applicant Contact Joe Shia
Correspondent
Healgen Scientific,, LLC
504 E. Diamnond Ave. Suite F
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Code
DJG  
Date Received06/19/2014
Decision Date 07/17/2014
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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