Home / 510(k) Clearances / K864604

510(k) K864604

EBV VCA IGM ANTIBODY ASSAY KIT by Granbio, Inc. — Product Code LJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1987
Date Received
November 24, 1986
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 Granbio, Inc.

  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K934774 — UNKNOWN (April 20, 1994)
  • K901156 — EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K901840 — (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K881617 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY (June 7, 1988)
  • K871298 — EBNA ACIF ASSAY KIT (June 25, 1987)
  • K864347 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA (February 2, 1987)

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)
  • K973939 — IMMUNOWELL VCA IGM TEST (August 10, 1998)
  • 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)