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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, Methadone
510(k) Number K052197
Device Name FIRST SIGN DRUG OF ABUSE URINE 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 Number862.3620
Classification Product Code
DJR  
Subsequent Product Codes
DIS   DJG   JXM   LAF   LFG  
Date Received08/12/2005
Decision Date 06/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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