The following data is part of a premarket notification filed by Denka Seiken Co., Ltd. with the FDA for Crp-latex (ii)x2 Seiken Assay Kit.
| Device ID | K030545 |
| 510k Number | K030545 |
| Device Name: | CRP-LATEX (II)X2 SEIKEN ASSAY KIT |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DENKA SEIKEN CO., LTD. KAGAMIDA FACILITY 1-2-2 MINAMIHONCHO, Gosen City, Niigata, JP 959-1695 |
| Contact | Toshimi Matsunaga |
| Correspondent | Toshimi Matsunaga DENKA SEIKEN CO., LTD. KAGAMIDA FACILITY 1-2-2 MINAMIHONCHO, Gosen City, Niigata, JP 959-1695 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-20 |
| Decision Date | 2003-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013514 | K030545 | 000 |
| 00811727011053 | K030545 | 000 |
| 00811727011046 | K030545 | 000 |
| 00811727011039 | K030545 | 000 |
| 00811727011022 | K030545 | 000 |
| 00811727016126 | K030545 | 000 |