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510(k) K822985

EBV-M KIT by Litton Bionetics — Product Code JRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
October 12, 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 Litton Bionetics

  • K840417 — EBNA ACIF KIT (December 27, 1984)
  • K834443 — ROTAVIRUS BIO-ENZABEAD SCREEN KIT (March 16, 1984)
  • K831343 — CMV RQ BIO-ENZABEAD KIT (August 8, 1983)
  • K821804 — RUBELLA RQ BIO-ENZABEAD KIT (September 14, 1982)
  • K801721 — HSV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801722 — CMV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)
  • K791614 — HSV BIO-BEAD SCREEN KIT (November 13, 1979)
  • K791618 — TORCH BIO-BEAD SCREEN KIT (November 13, 1979)

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)
  • 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)