VITROS Immunodiagnostic Products CEA Reagent Pack— 510(k) K231517
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K231517 for VITROS Immunodiagnostic Products CEA Reagent Pack, Substantially Equivalent on 2023-08-23. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code DHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgend, GB
Recent devices under product code DHX
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Data sourced from openFDA. This site is unofficial and independent of the FDA.