The following data is part of a premarket notification filed by Cella Vision Ab with the FDA for Advanced Rbc Application.
| Device ID | K171315 |
| 510k Number | K171315 |
| Device Name: | Advanced RBC Application |
| Classification | Device, Automated Cell-locating |
| Applicant | Cella Vision AB Ideon Science Park Lund, SE Se-223 70 |
| Contact | Cella Vision Ab |
| Correspondent | Constance G. Bundy CG Bundy LLC 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 | 2017-05-04 |
| Decision Date | 2017-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350040974759 | K171315 | 000 |
| 07350040973769 | K171315 | 000 |
| 07350040973752 | K171315 | 000 |
| 07350040973745 | K171315 | 000 |