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510(k) K896594

EBV VCA ANTIBODY (IGM) by Hillcrest Biologicals — Product Code LJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1990
Date Received
November 21, 1989
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 Hillcrest Biologicals

  • K913618 — ARBOVIRUS IGM IFA TEST (December 3, 1992)
  • K913617 — ARBOVIRUS IGG IFA TEST (December 3, 1992)
  • K922374 — Q FEVER IGM IFA TEST (October 21, 1992)
  • K913906 — Q FEVER IGG IFA TEST (October 21, 1992)
  • K900206 — LYME DISEASE IGM ELISA (June 28, 1991)
  • K884829 — EBV EARLY ANTIGEN (R+D) (April 12, 1989)
  • K883767 — LYME DISEASE IFA (IGM) (March 15, 1989)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K883487 — LYME DISEASE IFA (IGG) (December 13, 1988)
  • K875170 — EBNA ANTIBODY (May 23, 1988)

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)