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510(k) K911362

AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST by Amico Laboratories, Inc. — Product Code LJN

K911362 is an FDA 510(k) premarket notification submitted by Amico Laboratories, Inc. for the device "AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on October 7, 1991. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1991
Date Received
March 28, 1991
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 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)
  • 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)

FDA data resources