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510(k) K030863

EBV VCA-P18 IGG ELISA by Panbio Limited — Product Code LSE

K030863 is an FDA 510(k) premarket notification submitted by Panbio Limited for the device "EBV VCA-P18 IGG ELISA". The FDA issued a decision of Substantially Equivalent on June 27, 2003. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. Panbio Limited has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2003
Date Received
March 18, 2003
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 Panbio Limited

  • K041068 — WEST NILE VIRUS IGG INDIRECT ELISA (October 20, 2004)
  • K041231 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (August 10, 2004)
  • DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA (July 8, 2003)

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)
  • K021793 — EBV EA-D IGG ELISA KIT, MODEL EBG-100 (September 27, 2002)

FDA data resources