The following data is part of a premarket notification filed by Denka Seiken Co., Ltd. with the FDA for S Ldl-ex Seiken.
| Device ID | K161679 |
| 510k Number | K161679 |
| Device Name: | S LDL-EX SEIKEN |
| Classification | Low-density Lipoprotein (ldl) Cholesterol Sub-fraction Test |
| Applicant | DENKA SEIKEN CO., LTD. 1359-I, Kagamida, Kigoshi Gosen, JP 959-1695 |
| Contact | Takayoshi Ishii |
| Correspondent | Thomas M. Tsakeris DEVICES & DIAGNOSTICS CONSULTING GROUP, INC. 16809 Briardale Road Rockville, MD 20855 |
| Product Code | PYP |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-17 |
| Decision Date | 2017-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987503562807 | K161679 | 000 |
| 04987503562791 | K161679 | 000 |
| 04987503562760 | K161679 | 000 |
| 04987503562890 | K161679 | 000 |
| 04987503562883 | K161679 | 000 |
| 04987503562906 | K161679 | 000 |