The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for He4 Eia, Model: 404-10 Us.
| Device ID | K072939 |
| 510k Number | K072939 |
| Device Name: | HE4 EIA, MODEL: 404-10 US |
| Classification | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Diana L Dickson |
| Correspondent | Diana L 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 | 2007-10-17 |
| Decision Date | 2008-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350066140326 | K072939 | 000 |