Sysmex RA Co., LTD, Main Office
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010188766 | 3010188766 | Sysmex RA Co., LTD, Main Office | 1 | N | 2027-01-01 | 3034 Hirooka-Nomura Shiojiri Nagano JP 399-0702 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 149646 | 1131324119 | K031377 | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 | GKP | 2003-09-08 |
| 149646 | 1181515875 | ||||
| 149646 | 1254725906 | ||||
| 149646 | 1783397844 | ||||
| 149646 | 2071277566 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GKP | 1 | 2003-09-08 |