The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Ca 15-3 Assay.
| Device ID | K042732 |
| 510k Number | K042732 |
| Device Name: | ARCHITECT CA 15-3 ASSAY |
| Classification | System, Test, Immunological, Antigen, Tumor |
| 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 | MOI |
| 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 | 2004-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740145330 | K042732 | 000 |
| 00380740003326 | K042732 | 000 |
| 00380740003333 | K042732 | 000 |
| 00380740003340 | K042732 | 000 |
| 00380740003357 | K042732 | 000 |
| 00380740131432 | K042732 | 000 |
| 00380740131449 | K042732 | 000 |
| 00380740145293 | K042732 | 000 |
| 00380740145309 | K042732 | 000 |
| 00380740145316 | K042732 | 000 |
| 00380740145323 | K042732 | 000 |
| 00380740003319 | K042732 | 000 |