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510(k) K073381

PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M by Focus Diagnostics, Inc. — Product Code LJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2008
Date Received
December 3, 2007
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

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  • K120986 — STRATIFY JCV DXSELECT (August 16, 2012)
  • K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (July 13, 2012)
  • K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
  • DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)

Other clearances for product code LJN

  • K123021 — BIOPLEX 2200 EBV IGM KIT (November 2, 2012)
  • K042092 — ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM (April 12, 2005)
  • K033780 — MODIFICATION TO SERAQUEST VCA IGM (January 15, 2004)
  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
  • 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)