The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Glucose Control Solutions.
| Device ID | K033433 |
| 510k Number | K033433 |
| Device Name: | NOVA GLUCOSE CONTROL SOLUTIONS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-28 |
| Decision Date | 2004-01-02 |