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510(k) K821849

EBV-VCA ANTIBODY ASSAY KIT by Biotech Research Laboratories, Inc. — Product Code JRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1982
Date Received
June 23, 1982
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

Other clearances by Biotech Research Laboratories, Inc.

  • K853484 — INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT (February 5, 1986)

Other clearances for product code JRY

  • K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM (April 29, 2005)
  • 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)
  • K811262 — EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (May 27, 1981)
  • K780925 — EB-VCA, TEST, ANTIBODY, FLUORESCENT (June 22, 1978)