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510(k) K073381

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

K073381 is an FDA 510(k) premarket notification submitted by Focus Diagnostics, Inc. for the device "PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M". The FDA issued a decision of Substantially Equivalent on August 4, 2008. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Focus Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Focus Diagnostics, Inc.

  • K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (September 21, 2015)
  • K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (August 28, 2015)
  • K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)
  • K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (December 5, 2014)
  • K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (July 1, 2014)
  • DEN130049 — SIMPLEXA HSV 1&2 DIRECT (March 21, 2014)
  • 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)

FDA data resources