The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Celltrak 12 Auto Multi-para Hema Analyzer/cal.
| Device ID | K913259 |
| 510k Number | K913259 |
| Device Name: | NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL |
| Classification | Counter, Differential Cell |
| 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 | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-23 |
| Decision Date | 1991-10-08 |