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510(k) K982348

EBNA-1 IGM ELISA TEST SYSTEM by Columbia Bioscience, Inc. — Product Code LSE

K982348 is an FDA 510(k) premarket notification submitted by Columbia Bioscience, Inc. for the device "EBNA-1 IGM ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 1998. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. Columbia Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1998
Date Received
July 6, 1998
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 Columbia Bioscience, Inc.

  • K991274 — MUMPS IGG ELISA TEST SYSTEM (September 3, 1999)
  • K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM (September 3, 1999)
  • K984228 — IS ANTI-TPO IGG ELISA TEST SYSTEM (February 2, 1999)
  • K983606 — IS BORRELIA BURGDORFERI IGM TEST SYSTEM (December 16, 1998)
  • K983605 — IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (December 16, 1998)
  • K983553 — ANTI-TG IGG ELISA TEST SYSTEM (December 7, 1998)
  • K982352 — VCA IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982350 — EA-D IGM ELISA TEST SYSTEM (November 25, 1998)
  • K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM (November 18, 1998)
  • K983740 — IS-ANTI-PR3 IGG ELISA TEST SYSTEM (November 18, 1998)

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