The following data is part of a premarket notification filed by Denka Seiken's with the FDA for Crp-latex (ii) Seiken High Sensitivity Assay Kit.
| Device ID | K011958 |
| 510k Number | K011958 |
| Device Name: | CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT |
| Classification | System, Test, C-reactive Protein |
| Applicant | DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo, JP 103-0025 |
| Contact | Seiya Sato |
| Correspondent | Seiya Sato DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo, JP 103-0025 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-22 |
| Decision Date | 2001-12-04 |
| Summary: | summary |