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 | K200349 |
| 510k Number | K200349 |
| Device Name: | Stat Profile Prime Plus Analyzer System |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 |
| Contact | Rachel Gilbert |
| Correspondent | Rachel Gilbert Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 |
| Product Code | CGA |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CGL |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-12 |
| Decision Date | 2020-03-13 |