The following data is part of a premarket notification filed by Cellavision Ab with the FDA for Cellavision Dm1200 With The Body Fluid Appliction.
| Device ID | K102778 |
| 510k Number | K102778 |
| Device Name: | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION |
| Classification | Device, Automated Cell-locating |
| Applicant | CELLAVISION AB 435 RICE CREEK TERRACE NE Fridley, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy CELLAVISION AB 435 RICE CREEK TERRACE NE Fridley, 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 | 2010-09-24 |
| Decision Date | 2011-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350040974728 | K102778 | 000 |
| 07350040973707 | K102778 | 000 |
| 07350040973714 | K102778 | 000 |
| 07350040973776 | K102778 | 000 |
| 07350040974506 | K102778 | 000 |
| 07350040974513 | K102778 | 000 |
| 07350040974537 | K102778 | 000 |
| 07350040974568 | K102778 | 000 |
| 07350040974599 | K102778 | 000 |
| 07350040974698 | K102778 | 000 |
| 07350040974704 | K102778 | 000 |
| 07350040972557 | K102778 | 000 |