Stat Profile Prime ES Comp Plus Analyzer System— 510(k) K191626
Substantially EquivalentNova Biomedical Corporation
FDA 510(k) clearance K191626 for Stat Profile Prime ES Comp Plus Analyzer System, Substantially Equivalent on 2019-08-16. Applicant: Nova Biomedical Corporation.
Clearance details
- Applicant
- Nova Biomedical Corporation
- Product code
- Code JFP
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.