ORTHO CLG IMMUNE COMPLEX TEST SYSTEM— 510(k) K821806
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K821806 for ORTHO CLG IMMUNE COMPLEX TEST SYSTEM, Substantially Equivalent on 1982-06-25. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code DAK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Recent devices under product code DAK
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- 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.