Stat Profile Prime ES Comp Plus Analyzer System
FDA 510(k) clearance K191365 · decided 2019-07-19
Clearance details
- K-number
- K191365
- Device name
- Stat Profile Prime ES Comp Plus Analyzer System
- Applicant
- Nova Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-05-22
- Decision date
- 2019-07-19
- Days to decision
- 58 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
No recalls on record reference this clearance.