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510(k) K925689

MERIDIAN EBV-IGG TEST KIT by Fuller Laboratories, Inc. — Product Code MCD

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
Antigen, Ebv, Capsid
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)
  • K925690 — MERIDIAN EBNA TEST KIT (October 12, 1993)

Other clearances for product code MCD

  • K984126 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYM (January 11, 1999)
  • K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (June 13, 1994)
  • K924091 — EBV-VCA IGG ELISA TEST SYSTEM (January 11, 1993)
  • K920412 — MODIFIED ORTHO EBV VCA-IGG ELISA (June 22, 1992)
  • K911571 — EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (June 10, 1991)
  • K911570 — EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST (June 10, 1991)
  • K910872 — EBV IGG ELISA TEST (April 12, 1991)