The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova 16 Analyzer.
| Device ID | K945584 |
| 510k Number | K945584 |
| Device Name: | NOVA 16 ANALYZER |
| Classification | Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
| 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 | JJC |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGL |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JFL |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JPI |
| Subsequent Product Code | JPK |
| CFR Regulation Number | 862.2150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-02-08 |