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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemagglutination Inhibition, Methadone
510(k) Number K801509
Device Name HI-M-TEST FOR METHADONE TEST #2
Applicant
Technam, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Technam, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3620
Classification Product Code
DIW  
Date Received06/30/1980
Decision Date 07/14/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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