Stat Profile Prime Plus Analyzer System
FDA 510(k) clearance K180186 · decided 2018-08-23
Clearance details
- K-number
- K180186
- Device name
- Stat Profile Prime Plus Analyzer System
- Applicant
- Nova Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-01-23
- Decision date
- 2018-08-23
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- GGZ
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Stat Profile Prime Plus Analyzer System (K200204) | Nova Biomedical Corporation | 2020-04-06 |
Recalls involving this device
No recalls on record reference this clearance.