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 |