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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Epstein-Barr Virus, Other
510(k) Number K974244
Device Name IMMUNODOT MONO-M TEST
Applicant
Genbio
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Applicant Contact Bryan Kiehl
Correspondent
Genbio
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Correspondent Contact Bryan Kiehl
Regulation Number866.3235
Classification Product Code
LSE  
Date Received11/12/1997
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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