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510(k) K990977

SERAQUEST EB VAC IGM by Quest Intl., Inc. — Product Code LJN

K990977 is an FDA 510(k) premarket notification submitted by Quest Intl., Inc. for the device "SERAQUEST EB VAC IGM". The FDA issued a decision of Substantially Equivalent on October 6, 1999. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), 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
October 6, 1999
Date Received
March 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibody Igm, If, Epstein-Barr Virus
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)
  • K991975 — SERAQUEST EB NA IGG (November 2, 1999)
  • K990410 — SERAQUEST EB VCA IGG (October 28, 1999)
  • K982485 — SERAQUEST CMV IGM (January 13, 1999)
  • K982281 — SERAQUEST RUBELLA IGM (October 16, 1998)

Other clearances for product code LJN

  • K123021 — BIOPLEX 2200 EBV IGM KIT (November 2, 2012)
  • K073381 — PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (August 4, 2008)
  • K042092 — ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM (April 12, 2005)
  • K033780 — MODIFICATION TO SERAQUEST VCA IGM (January 15, 2004)
  • K991459 — COPALIS EBV-M ANTIBODY ASSAY (May 14, 1999)
  • K973939 — IMMUNOWELL VCA IGM TEST (August 10, 1998)
  • K931520 — EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY (April 26, 1994)
  • K930020 — ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA (July 16, 1993)
  • K922331 — BARTELS EPSTEIN-BARR VIRUS IGM EIA (September 2, 1992)
  • K915348 — EBV-VCA IGM ELISA (February 14, 1992)

FDA data resources