The following data is part of a premarket notification filed by Cellavision Ab with the FDA for Diffmaster Octavia Automatic Hematology Analyzer.
| Device ID | K003301 |
| 510k Number | K003301 |
| Device Name: | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER |
| Classification | Device, Automated Cell-locating |
| Applicant | CELLAVISION AB 6740 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy CELLAVISION AB 6740 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-20 |
| Decision Date | 2001-03-15 |
| Summary: | summary |