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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K851635
Device Name DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
Applicant
Diagnon Corp.
Phair Office Park
1050 W. St.
Laurel,  MD  20707
Applicant Contact WILLIAM C GORDON
Correspondent
Diagnon Corp.
Phair Office Park
1050 W. St.
Laurel,  MD  20707
Correspondent Contact WILLIAM C GORDON
Regulation Number866.3305
Classification Product Code
GQL  
Date Received04/18/1985
Decision Date 10/10/1985
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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