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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Antigen, Nuclear, Epstein-Barr Virus
510(k) Number K840417
Device Name EBNA ACIF KIT
Applicant
Litton Bionetics
2020 Bridge View Dr.
Charleston,  SC  29405 -
Applicant Contact DALE KIRKBRIDE
Correspondent
Litton Bionetics
2020 Bridge View Dr.
Charleston,  SC  29405 -
Correspondent Contact DALE KIRKBRIDE
Regulation Number866.3235
Classification Product Code
LLM  
Date Received01/31/1984
Decision Date 12/27/1984
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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