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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Test Isoniazid
510(k) Number K912888
Device Name URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
Applicant
Dynagen, Inc.
99 Erie St.,
Cambridge,  MA  02139
Applicant Contact PETER J MIONE
Correspondent
Dynagen, Inc.
99 Erie St.,
Cambridge,  MA  02139
Correspondent Contact PETER J MIONE
Classification Product Code
MIG  
Date Received07/01/1991
Decision Date 02/24/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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