The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Ca 19-9xr Assay.
| Device ID | K052000 |
| 510k Number | K052000 |
| Device Name: | ARCHITECT CA 19-9XR ASSAY |
| Classification | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Diana L Wolaniuk |
| Correspondent | Diana L Wolaniuk FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | NIG |
| 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 | 2005-07-25 |
| Decision Date | 2005-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740155919 | K052000 | 000 |
| 00380740145408 | K052000 | 000 |
| 00380740145392 | K052000 | 000 |
| 00380740137304 | K052000 | 000 |
| 00380740105464 | K052000 | 000 |
| 00380740003562 | K052000 | 000 |
| 00380740003555 | K052000 | 000 |