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510(k) K931443

ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS by Ortho Diagnostic Systems, Inc. — Product Code LSE

K931443 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS". The FDA issued a decision of Substantially Equivalent on Nov 5, 1993. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 5, 1993
Date Received
Mar 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Ortho Diagnostic Systems, Inc.

  • K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE (Jul 14, 1997)
  • K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) (Mar 6, 1997)
  • K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE (Jan 22, 1997)
  • K963902 — QUANTITATIVE FIBRINOGEN ASSAY (Nov 29, 1996)
  • K951100 — ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950625 — ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950482 — ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) (May 10, 1996)
  • K935720 — ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTE (May 9, 1996)
  • K954570 — ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM (Apr 30, 1996)

Other clearances for product code LSE

  • K233606 — ADVIA Centaur EBV-VCA IgM (Aug 7, 2024)
  • K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and L (Jan 5, 2017)
  • K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (Jan 4, 2017)
  • K091260 — SERAQUEST EBV EA-D IGG TEST (Jun 8, 2009)
  • K073382 — PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (Jul 28, 2008)
  • K062211 — BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (Dec 8, 2006)
  • K062213 — BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (Dec 8, 2006)
  • K060204 — LIAISON EA IGG (Oct 18, 2006)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (Jan 16, 2004)
  • K030863 — EBV VCA-P18 IGG ELISA (Jun 27, 2003)

FDA data resources