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510(k) K973941

IMMUNOWELL EBNA IGG TEST by Genbio — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1998
Date Received
October 15, 1997
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 Genbio

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  • K974244 — IMMUNODOT MONO-M TEST (September 22, 1998)
  • K973939 — IMMUNOWELL VCA IGM TEST (August 10, 1998)
  • K973940 — IMMUNOWELL EBV VCA IGG TEST (August 10, 1998)
  • K963054 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (May 5, 1997)
  • K963055 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (May 2, 1997)
  • K953683 — MMUNO DOT BORRELIA DOT BLOT M TEST (May 3, 1996)
  • K953682 — IMMUNO DOT BORRELIA DOT BLOT G TEST (May 3, 1996)

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)
  • 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)
  • K932742 — EBNA IGG ELISA TEST SYSTEM (May 5, 1995)