The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay C-reactive Protein (3), K-assay Crp Multi-calibrator D, K-assay Crp Multi-calibrator E, K-assay Crp Multi-calibr.
| Device ID | K023828 |
| 510k Number | K023828 |
| Device Name: | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Contact | Brian Schliesman |
| Correspondent | Brian Schliesman KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-18 |
| Decision Date | 2003-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426021259 | K023828 | 000 |
| 00816426020641 | K023828 | 000 |
| 00816426020634 | K023828 | 000 |
| 00816426020344 | K023828 | 000 |