The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Architect He4, Architect He4 Calibrators And Architect He4 Controls, Models 2, 2p54, 2p54-01, 2p54-10 Sp54-01,.
| Device ID | K093957 |
| 510k Number | K093957 |
| Device Name: | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, |
| Classification | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
| Applicant | FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 -1307 |
| Contact | Stacey Dolan |
| Correspondent | Stacey Dolan FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern, PA 19355 -1307 |
| Product Code | OIU |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740138349 | K093957 | 000 |
| 00380740048433 | K093957 | 000 |
| 00380740003982 | K093957 | 000 |
| 00380740003975 | K093957 | 000 |