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510(k) K840417

EBNA ACIF KIT by Litton Bionetics — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1984
Date Received
January 31, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Litton Bionetics

  • K834443 — ROTAVIRUS BIO-ENZABEAD SCREEN KIT (March 16, 1984)
  • K831343 — CMV RQ BIO-ENZABEAD KIT (August 8, 1983)
  • K822985 — EBV-M KIT (December 3, 1982)
  • 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)
  • K791612 — CMV BIO-BEAD SCREEN KIT (November 13, 1979)
  • K791614 — HSV BIO-BEAD SCREEN KIT (November 13, 1979)

Other clearances for product code LLM

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  • K040120 — DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (April 29, 2005)
  • K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME L (January 11, 1999)
  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 1998)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (July 21, 1995)
  • K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (June 9, 1995)