The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova 13 Analyzer.
| Device ID | K912561 |
| 510k Number | K912561 |
| Device Name: | NOVA 13 ANALYZER |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Mcdonald |
| Correspondent | Paul W Mcdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | CGZ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-11 |
| Decision Date | 1991-09-11 |