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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cannabinoid(S)
510(k) Number K936135
Device Name SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION
Applicant
Sudormed, Inc.
12341 Newport Ave., #D-200
Santa Ana,  CA  92705
Applicant Contact JON BOOHER, PH.D.
Correspondent
Sudormed, Inc.
12341 Newport Ave., #D-200
Santa Ana,  CA  92705
Correspondent Contact JON BOOHER, PH.D.
Regulation Number862.3870
Classification Product Code
LAT  
Date Received12/28/1993
Decision Date 06/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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