The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Celltrak 11 Auto. Hema. Analyzer, Calibrators.
| Device ID | K884618 |
| 510k Number | K884618 |
| Device Name: | NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS |
| Classification | Counter, Cell, Automated (particle Counter) |
| 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 | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-04 |
| Decision Date | 1989-01-24 |