The following data is part of a premarket notification filed by Cellavision Ab with the FDA for Cellavision Dc-1, Cellavision Dc-1 Ppa.
| Device ID | K200595 |
| 510k Number | K200595 |
| Device Name: | CellaVision DC-1, CellaVision DC-1 PPA |
| Classification | Device, Automated Cell-locating |
| Applicant | CellaVision AB Mobilvagen 12 Lund, SE 22362 |
| Contact | Magnus Johnsson |
| Correspondent | Jinjie Hu Axteria BioMed Consulting Inc. 8040 Cobble Creek Circle Potomac, MD 20854 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-06 |
| Decision Date | 2020-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350040975107 | K200595 | 000 |
| 07350040975091 | K200595 | 000 |