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510(k) K924091

EBV-VCA IGG ELISA TEST SYSTEM by Zeus Scientific, Inc. — Product Code MCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1993
Date Received
August 13, 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

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