Stat Profile Prime ES Comp Plus Analyzer System— 510(k) K191365
Substantially EquivalentNova Biomedical Corporation
FDA 510(k) clearance K191365 for Stat Profile Prime ES Comp Plus Analyzer System, Substantially Equivalent on 2019-07-19. Applicant: Nova Biomedical Corporation.
Clearance details
- Applicant
- Nova Biomedical Corporation
- Product code
- Code JGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, 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.