VITROS XT Chemistry Products GLU-Ca Slides— 510(k) K190520
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K190520 for VITROS XT Chemistry Products GLU-Ca Slides, Substantially Equivalent on 2019-04-03. Applicant: Ortho-Clinical Diagnostics, Inc..
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code CGA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
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.