The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Tp-n Immunoreaction Cartridge Set.
| Device ID | K153145 |
| 510k Number | K153145 |
| Device Name: | Lumipulse G TP-N Immunoreaction Cartridge Set |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Contact | Diana Dickson |
| Correspondent | Diana Dickson Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-30 |
| Decision Date | 2016-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987270235041 | K153145 | 000 |