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510(k) K991975

SERAQUEST EB NA IGG by Quest Intl., Inc. — Product Code LSE

K991975 is an FDA 510(k) premarket notification submitted by Quest Intl., Inc. for the device "SERAQUEST EB NA IGG". The FDA issued a decision of Substantially Equivalent on November 2, 1999. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. Quest Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1999
Date Received
June 11, 1999
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 Quest Intl., Inc.

  • K091260 — SERAQUEST EBV EA-D IGG TEST (June 8, 2009)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (January 16, 2004)
  • K033780 — MODIFICATION TO SERAQUEST VCA IGM (January 15, 2004)
  • K023593 — SERAQUEST ANTI-THYROID PEROXIDASE (TPO) (February 6, 2003)
  • K023592 — SERAQUEST ANTI-THYROGLOBULIN (January 6, 2003)
  • K003069 — ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM (November 27, 2000)
  • K990410 — SERAQUEST EB VCA IGG (October 28, 1999)
  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
  • K982485 — SERAQUEST CMV IGM (January 13, 1999)
  • K982281 — SERAQUEST RUBELLA IGM (October 16, 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