The following data is part of a premarket notification filed by Denka Seiken Co., Ltd. with the FDA for Hdl-ex Seiken Assay Kit.
| Device ID | K041090 |
| 510k Number | K041090 |
| Device Name: | HDL-EX SEIKEN ASSAY KIT |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | DENKA SEIKEN CO., LTD. 1-2-2, MINAMIHONCHO, GOSEN CITY Niigata, JP 959-1695 |
| Contact | Toshimi Matsunaga |
| Correspondent | Toshimi Matsunaga DENKA SEIKEN CO., LTD. 1-2-2, MINAMIHONCHO, GOSEN CITY Niigata, JP 959-1695 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-10-29 |
| Summary: | summary |