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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K931105
Device Name PROCHECK(TM) BLIND PERFORMANCE SPECIMENS
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 Number862.3280
Classification Product Code
DIF  
Date Received03/03/1993
Decision Date 04/21/1993
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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