The following data is part of a premarket notification filed by Dakocytomation California, Inc. with the FDA for Cyan Dxd, Multitest Cd8/cd4/cd3, Cd3-fitc, Cd3-rpe, Cd3-apc And Fluorospheres.
| Device ID | K060423 |
| 510k Number | K060423 |
| Device Name: | CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES |
| Classification | Counter, Differential Cell |
| Applicant | DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Tiffany D Almeroth |
| Correspondent | Tiffany D Almeroth DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL Carpinteria, CA 93013 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-17 |
| Decision Date | 2006-08-15 |
| Summary: | summary |