The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Fujirebio Diagnostics Tumor Marker Control.
| Device ID | K103676 |
| 510k Number | K103676 |
| Device Name: | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL |
| Classification | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Diana Lyn Dickson |
| Correspondent | Diana Lyn Dickson FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | OIU |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-16 |
| Decision Date | 2011-07-19 |
| Summary: | summary |