The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Ca 125 Ii Assay.
| Device ID | K042731 |
| 510k Number | K042731 |
| Device Name: | ARCHITECT CA 125 II ASSAY |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Kimberly Peterson |
| Correspondent | Kimberly Peterson FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | LTK |
| 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 | 2004-10-01 |
| Decision Date | 2004-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740145385 | K042731 | 000 |
| 00380740003364 | K042731 | 000 |
| 00380740003371 | K042731 | 000 |
| 00380740003388 | K042731 | 000 |
| 00380740003395 | K042731 | 000 |
| 00380740003401 | K042731 | 000 |
| 00380740131050 | K042731 | 000 |
| 00380740145347 | K042731 | 000 |
| 00380740145354 | K042731 | 000 |
| 00380740145361 | K042731 | 000 |
| 00380740145378 | K042731 | 000 |
| 00380740131043 | K042731 | 000 |