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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 K792559
Device Name FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
Applicant
Intl. Diagnostic Technology
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Intl. Diagnostic Technology
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3305
Classification Product Code
GQL  
Date Received12/11/1979
Decision Date 03/03/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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