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510(k) K932742

EBNA IGG ELISA TEST SYSTEM by Zeus Scientific, Inc. — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1995
Date Received
June 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

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