ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS— 510(k) K931443
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K931443 for ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS, Substantially Equivalent on 1993-11-05. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Recent devices under product code LSE
view all- K233606 — ADVIA Centaur EBV-VCA IgM
- K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
- K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
- K091260 — SERAQUEST EBV EA-D IGG TEST
- K073382 — PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
More clearances from Ortho Diagnostic Systems, Inc.
view all- K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
- K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
- K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
- K963902 — QUANTITATIVE FIBRINOGEN ASSAY
- K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.