The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Total Protein Module.
| Device ID | K923266 |
| 510k Number | K923266 |
| Device Name: | NOVA TOTAL PROTEIN MODULE |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-02 |
| Decision Date | 1992-08-12 |