The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Stat Profile Prime Plus Analyzer System.
| Device ID | K180186 |
| 510k Number | K180186 |
| Device Name: | Stat Profile Prime Plus Analyzer System |
| Classification | Oxyhemoglobin |
| Applicant | Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 |
| Contact | Adam Heroux |
| Correspondent | Cesidio Tempesta Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 |
| Product Code | GGZ |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKK |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JPI |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-23 |
| Decision Date | 2018-08-23 |
| Summary: | summary |