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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 K992587
Device Name EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
Applicant
Stellar Bio Systems, Inc.
9075 Guilford Rd.
Columbia,  MD  21046
Applicant Contact JOHN BREWER
Correspondent
Stellar Bio Systems, Inc.
9075 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact JOHN BREWER
Regulation Number866.3235
Classification Product Code
LSE  
Date Received08/02/1999
Decision Date 12/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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