The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova 1 Sodium/potassium/hematocrit Analyzer.
| Device ID | K912559 |
| 510k Number | K912559 |
| Device Name: | NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-11 |
| Decision Date | 1991-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480156462 | K912559 | 000 |
| 00385480135245 | K912559 | 000 |
| 00385480135238 | K912559 | 000 |
| 10385480132111 | K912559 | 000 |
| 00385480000185 | K912559 | 000 |