The following data is part of a premarket notification filed by Denka Seiken Co., Ltd. with the FDA for Crp (ii) Calibrators.
| Device ID | K030546 |
| 510k Number | K030546 |
| Device Name: | CRP (II) CALIBRATORS |
| Classification | Calibrator, Primary |
| 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 | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| 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 |