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510(k) K925690

MERIDIAN EBNA TEST KIT by Fuller Laboratories, Inc. — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1993
Date Received
November 12, 1992
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

Other clearances by Fuller Laboratories, Inc.

  • K931557 — FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST (March 11, 1994)
  • K925688 — MERIDIAN EBV-EA TEST KIT (October 12, 1993)
  • K925689 — MERIDIAN EBV-IGG TEST KIT (October 12, 1993)

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  • K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME L (January 11, 1999)
  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 1998)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (July 21, 1995)
  • K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (June 9, 1995)