The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Ii Sodium/potassium/lithium Analyzer.
| Device ID | K863438 |
| 510k Number | K863438 |
| Device Name: | NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER |
| Classification | Electrode, Ion Selective (non-specified) |
| 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 | JJP |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-05 |
| Decision Date | 1986-09-29 |