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 |