The following data is part of a premarket notification filed by Cellavision Ab with the FDA for Cellavision Dm1200 Automated Hematology Analyzer, Model Xu-10127.
| Device ID | K092868 |
| 510k Number | K092868 |
| Device Name: | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-18 |
| Decision Date | 2009-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350040975930 | K092868 | 000 |
| 07350040972021 | K092868 | 000 |
| 07350040974322 | K092868 | 000 |
| 07350040974544 | K092868 | 000 |
| 07350040974551 | K092868 | 000 |
| 07350040974575 | K092868 | 000 |
| 07350040975893 | K092868 | 000 |
| 07350040975909 | K092868 | 000 |
| 07350040975916 | K092868 | 000 |
| 07350040975923 | K092868 | 000 |
| 07350040971277 | K092868 | 000 |