The following data is part of a premarket notification filed by Cellavision Ab with the FDA for Cellavision Dm96 With The Body Fluid Application.
| Device ID | K080595 |
| 510k Number | K080595 |
| Device Name: | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION |
| 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 | 2008-03-03 |
| Decision Date | 2008-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350040972564 | K080595 | 000 |