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510(k) K935730

EBNA IGG ELISA TEST by Gull Laboratories, Inc. — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1995
Date Received
December 1, 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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  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)
  • K922759 — HSV-2 IGM ELISA TEST--MODIFICATION (October 5, 1992)

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  • K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (June 9, 1995)
  • K932742 — EBNA IGG ELISA TEST SYSTEM (May 5, 1995)