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510(k) K931520

EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY by Mrl Diagnostics — Product Code LJN

K931520 is an FDA 510(k) premarket notification submitted by Mrl Diagnostics for the device "EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Mrl Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1994
Date Received
March 26, 1993
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 Mrl Diagnostics

  • K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (April 14, 2000)
  • K993754 — HSV-1 ELISA IGG, MODEL EL0910G (February 9, 2000)
  • K993724 — HSV-2 ELISA IGG, MODEL EL0920G (February 1, 2000)
  • K971006 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) (June 1, 1998)
  • K971007 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) (June 1, 1998)
  • K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (July 21, 1995)

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)
  • 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