VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack— 510(k) K233581
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K233581 for VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack, Substantially Equivalent on 2024-05-08. Applicant: Ortho Clinical Diagnostics.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code DHA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgend, GB
Adverse events under product code DHA
product code DHA- Malfunction
- 1,242
- Total
- 1,242
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.