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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antiserum, fluorescent, epstein-barr virus
510(k) Number K780925
Device Name EB-VCA, TEST, ANTIBODY, FLUORESCENT
Applicant
LITTON BIONETICS
Correspondent
LITTON BIONETICS
Regulation Number866.3235
Classification Product Code
JRY  
Date Received06/06/1978
Decision Date 06/22/1978
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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