The following data is part of a premarket notification filed by Fujirebio Dianostics, Inc. with the FDA for Lumpipulse G Ca19-9-n.
| Device ID | K191973 |
| 510k Number | K191973 |
| Device Name: | Lumpipulse G CA19-9-N |
| Classification | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Applicant | Fujirebio Dianostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Contact | Kristin Maddaloni |
| Correspondent | Kristin Maddaloni Fujirebio Dianostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 |
| Product Code | NIG |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-24 |
| Decision Date | 2019-10-22 |
| Summary: | summary |