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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Mycobacteria
510(k) Number K943049
Device Name MYCOAKT M. AVIUM CULTURE ID KIT
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
Regulation Number866.2660
Classification Product Code
JSY  
Date Received06/27/1994
Decision Date 03/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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