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510(k) K925690

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

K925690 is an FDA 510(k) premarket notification submitted by Fuller Laboratories, Inc. for the device "MERIDIAN EBNA TEST KIT". The FDA issued a decision of Substantially Equivalent on October 12, 1993. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Fuller Laboratories, Inc. has at least 3 other 510(k) clearances on record.

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)
  • K925689 — MERIDIAN EBV-IGG TEST KIT (October 12, 1993)
  • K925688 — MERIDIAN EBV-EA TEST KIT (October 12, 1993)

Other clearances for product code LLM

  • K233605 — ADVIA Centaur EBV-EBNA IgG (August 7, 2024)
  • K040120 — DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (April 29, 2005)
  • 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)

FDA data resources