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510(k) K984126

THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR by Zeus Scientific, Inc. — Product Code MCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1999
Date Received
November 18, 1998
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

  • K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (June 13, 1994)
  • K925689 — MERIDIAN EBV-IGG TEST KIT (October 12, 1993)
  • 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)