The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay High Sensitive Crp(2) For The Beckman Coulter Immage.
| Device ID | K002558 |
| 510k Number | K002558 |
| Device Name: | K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Contact | Colin Getty |
| Correspondent | Colin Getty KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2000-10-25 |