Stat Profile Prime Plus Analyzer System— 510(k) K200349
Substantially EquivalentNova Biomedical Corporation
FDA 510(k) clearance K200349 for Stat Profile Prime Plus Analyzer System, Substantially Equivalent on 2020-03-13. Applicant: Nova Biomedical Corporation.
Clearance details
- Applicant
- Nova Biomedical Corporation
- Product code
- Code CGA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, 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.