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510(k) K010301

IMMUNOWELL EA (D) IGG TEST by Genbio — Product Code LSE

K010301 is an FDA 510(k) premarket notification submitted by Genbio for the device "IMMUNOWELL EA (D) IGG TEST". The FDA issued a decision of Substantially Equivalent on June 11, 2001. The device falls under product code LSE (Epstein-Barr Virus, Other), 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
June 11, 2001
Date Received
February 1, 2001
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 Genbio

  • K974226 — IMMUNODOT MONO-G TEST (September 22, 1998)
  • K974244 — IMMUNODOT MONO-M TEST (September 22, 1998)
  • K973939 — IMMUNOWELL VCA IGM TEST (August 10, 1998)
  • K973940 — IMMUNOWELL EBV VCA IGG TEST (August 10, 1998)
  • K973941 — IMMUNOWELL EBNA 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 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