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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Ebv, Capsid
510(k) Number K925689
Device Name MERIDIAN EBV-IGG TEST KIT
Applicant
Fuller Laboratories, Inc.
2478 E. Fender, Unit 1
Fullerton,  CA  92631
Applicant Contact LEE FULLER
Correspondent
Fuller Laboratories, Inc.
2478 E. Fender, Unit 1
Fullerton,  CA  92631
Correspondent Contact LEE FULLER
Regulation Number866.3235
Classification Product Code
MCD  
Date Received11/12/1992
Decision Date 10/12/1993
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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