The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Lumipulse G Ca19-9-n.
| Device ID | K200997 |
| 510k Number | K200997 |
| Device Name: | Lumipulse G CA19-9-N |
| Classification | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Contact | Kristin Maddaloni |
| Correspondent | Kristin Maddaloni Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Product Code | NIG |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-16 |
| Decision Date | 2020-05-14 |