Home / 510(k) Clearances / K973939

510(k) K973939

IMMUNOWELL VCA IGM TEST by Genbio — Product Code LJN

K973939 is an FDA 510(k) premarket notification submitted by Genbio for the device "IMMUNOWELL VCA IGM TEST". The FDA issued a decision of Substantially Equivalent on August 10, 1998. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Genbio has at least 9 other 510(k) clearances on record.

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
Antibody Igm, If, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Genbio

  • K010301 — IMMUNOWELL EA (D) IGG TEST (June 11, 2001)
  • K974244 — IMMUNODOT MONO-M TEST (September 22, 1998)
  • K974226 — IMMUNODOT MONO-G TEST (September 22, 1998)
  • K973941 — IMMUNOWELL EBNA IGG 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)
  • K953682 — IMMUNO DOT BORRELIA DOT BLOT G TEST (May 3, 1996)
  • K953683 — MMUNO DOT BORRELIA DOT BLOT M TEST (May 3, 1996)

Other clearances for product code LJN

  • K123021 — BIOPLEX 2200 EBV IGM KIT (November 2, 2012)
  • K073381 — PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (August 4, 2008)
  • K042092 — ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM (April 12, 2005)
  • K033780 — MODIFICATION TO SERAQUEST VCA IGM (January 15, 2004)
  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
  • K991459 — COPALIS EBV-M ANTIBODY ASSAY (May 14, 1999)
  • K931520 — EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY (April 26, 1994)
  • K930020 — ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA (July 16, 1993)
  • K922331 — BARTELS EPSTEIN-BARR VIRUS IGM EIA (September 2, 1992)
  • K915348 — EBV-VCA IGM ELISA (February 14, 1992)

FDA data resources