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 |