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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
510(k) Number K854974
Device Name HSV IDR
Applicant
Genus Diagnostics
225 Wildwood St.
Woburn,  MA  01801
Applicant Contact MARK P BEAR
Correspondent
Genus Diagnostics
225 Wildwood St.
Woburn,  MA  01801
Correspondent Contact MARK P BEAR
Regulation Number866.3305
Classification Product Code
GQN  
Date Received12/12/1985
Decision Date 03/07/1986
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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