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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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