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510(k) K933251

EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST by Virion (U.S.), Inc. — Product Code MCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1994
Date Received
July 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ebv, Capsid
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

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