VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927— 510(k) K091861
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K091861 for VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927, Substantially Equivalent on 2009-09-03. Applicant: Ortho-Clinical Diagnostics, Inc..
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code JGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
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.