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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 K883871
Device Name EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
Applicant
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Applicant Contact MARYLOU PANICO
Correspondent
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Correspondent Contact MARYLOU PANICO
Regulation Number866.3235
Classification Product Code
LSE  
Date Received09/13/1988
Decision Date 07/14/1989
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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