The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Chemistry Controls With Creatinine, Levels (1, 2) And 3.
| Device ID | K962997 |
| 510k Number | K962997 |
| Device Name: | NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-02 |
| Decision Date | 1996-08-15 |