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510(k) K021793

EBV EA-D IGG ELISA KIT, MODEL EBG-100 by Pan Bio Pty. , Ltd. — Product Code LSE

K021793 is an FDA 510(k) premarket notification submitted by Pan Bio Pty. , Ltd. for the device "EBV EA-D IGG ELISA KIT, MODEL EBG-100". The FDA issued a decision of Substantially Equivalent on September 27, 2002. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. Pan Bio Pty. , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2002
Date Received
May 31, 2002
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 Pan Bio Pty. , Ltd.

  • K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200 (June 13, 2002)
  • K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (June 13, 2002)
  • K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100 (June 13, 2002)

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)

FDA data resources