FDA Product Code
FDA Product Code GGZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7500
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200204 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-04-06 | Traditional | PDF ↗ |
| K180186 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-08-23 | Traditional | PDF ↗ |
Product code GGZ · Class II · Hematology. Data: openFDA.