Home / 510(k) Clearances / K934774

510(k) K934774

UNKNOWN by Granbio, Inc. — Product Code LSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1994
Date Received
October 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
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)
  • K901840 — (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K901156 — EIA FOR IGG 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)
  • K864604 — EBV VCA IGM ANTIBODY ASSAY KIT (February 2, 1987)

Other clearances for product code LSE

  • K233606 — ADVIA Centaur EBV-VCA IgM (August 7, 2024)
  • K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and L (January 5, 2017)
  • K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (January 4, 2017)
  • K091260 — SERAQUEST EBV EA-D IGG TEST (June 8, 2009)
  • K073382 — PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (July 28, 2008)
  • K062211 — BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (December 8, 2006)
  • K062213 — BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (December 8, 2006)
  • K060204 — LIAISON EA IGG (October 18, 2006)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (January 16, 2004)
  • K030863 — EBV VCA-P18 IGG ELISA (June 27, 2003)