The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Fujirebio Diagnostics Ca 19-9 Ria.
| Device ID | K020566 |
| 510k Number | K020566 |
| Device Name: | FUJIREBIO DIAGNOSTICS CA 19-9 RIA |
| Classification | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Daniel J O'shannessy |
| Correspondent | Daniel J O'shannessy FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | NIG |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-20 |
| Decision Date | 2002-05-09 |
| Summary: | summary |