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510(k) K946158

INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT by Incstar Corp. — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1995
Date Received
December 8, 1994
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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  • K955362 — INCSTAR HSV I/II IGG FAST ELISA ASSAY (July 24, 1996)
  • K955360 — INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY (July 22, 1996)

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