ORTHO SPECTRUM III & ORTHO-MUNE OK— 510(k) K820643
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K820643 for ORTHO SPECTRUM III & ORTHO-MUNE OK, Substantially Equivalent on 1982-07-14. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code LIZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Recent devices under product code LIZ
view allMore 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.