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510(k) K042118

ATHENA MULTI-LYTE EBV IGG TEST SYSTEM by Zeus Scientific, Inc. — Product Code JRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2005
Date Received
August 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

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Other clearances for product code JRY

  • K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (April 16, 1990)
  • K891785 — BION EBV-G (VCA) TEST SYSTEM (August 31, 1989)
  • K884829 — EBV EARLY ANTIGEN (R+D) (April 12, 1989)
  • K822734 — EBV IGM TEST (December 9, 1982)
  • K822985 — EBV-M KIT (December 3, 1982)
  • K821849 — EBV-VCA ANTIBODY ASSAY KIT (August 12, 1982)
  • K811262 — EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (May 27, 1981)
  • K780925 — EB-VCA, TEST, ANTIBODY, FLUORESCENT (June 22, 1978)