Stat Profile Prime Plus Analyzer System
FDA 510(k) clearance K200403 · decided 2020-04-14
Clearance details
- K-number
- K200403
- Device name
- Stat Profile Prime Plus Analyzer System
- Applicant
- Nova Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-02-19
- Decision date
- 2020-04-14
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, pl recall (Z-0207-2024) | Nova Biomedical Corporation | 2023-11-01 |
| Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, recall (Z-0208-2024) | Nova Biomedical Corporation | 2023-11-01 |