Lumipulse G BRAHMS PCT Immunoreaction Cartridges - 235058
2018-04-02
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014643041 | 3014643041 | Fujirebio Inc. Ube Facility | 1 | N | 2026-01-01 | 203-152, Aza-Ushiake, Oaza-Yoshiwa Ube-shi Yamaguchi JP 759-0134 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04987270226964 | Beckman Coulter PK TP System - 226964 | 800-223-0125 | xx@xx.xx |
| 04987270226964 | Beckman Coulter PK TP System - 226964 | 800-447-5852 | xx@xx.xx |
| 04987270230466 | Lumipulse G Dilution Cartridges - 230466 | 610-240-3800 | customersupport@fdi.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 324497 | 1323341184 | K971502 | SERODIA TP-PA | GMT | 1997-11-13 |
| 324497 | 1718059391 | K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | LTK | 2015-05-21 |
| 324497 | 1271170604 | BK200476 | |||
| 324497 | 1494908573 | BK070030 |
2018-04-02
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