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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 K032575
Device Name FIRST SIGN DRUG OF ABUSE SCREENING TEST
Applicant
W.H.P.M., Inc.
163 Cabot St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
W.H.P.M., Inc.
163 Cabot St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJC   DJG   DKE   LCM  
Date Received08/20/2003
Decision Date 05/19/2004
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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