Stat Profile Prime Plus Analyzer System
FDA 510(k) clearance K180340 · decided 2018-09-26
Clearance details
- K-number
- K180340
- Device name
- Stat Profile Prime Plus Analyzer System
- Applicant
- Nova Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-02-07
- Decision date
- 2018-09-26
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- 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.