The following data is part of a premarket notification filed by Denka Seiken's with the FDA for Lp(a)-latex Seiken Assay Kit.
| Device ID | K013359 |
| 510k Number | K013359 |
| Device Name: | LP(A)-LATEX SEIKEN ASSAY KIT |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo, JP 103-0025 |
| Contact | Yousuke Meguro |
| Correspondent | Yousuke Meguro DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU Tokyo, JP 103-0025 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-10 |
| Decision Date | 2002-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727011831 | K013359 | 000 |
| 00811727011824 | K013359 | 000 |
| 00817439021090 | K013359 | 000 |
| 00817439021069 | K013359 | 000 |