The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Bnp Assay, Model 8k28.
| Device ID | K060964 |
| 510k Number | K060964 |
| Device Name: | ARCHITECT BNP ASSAY, MODEL 8K28 |
| Classification | Test, Natriuretic Peptide |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Diana L Wolaniuk |
| Correspondent | Diana L Wolaniuk FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | NBC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2006-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740145286 | K060964 | 000 |
| 00380740190378 | K060964 | 000 |
| 00380740017460 | K060964 | 000 |
| 00380740017477 | K060964 | 000 |
| 00380740017484 | K060964 | 000 |
| 00380740017491 | K060964 | 000 |
| 00380740145255 | K060964 | 000 |
| 00380740145262 | K060964 | 000 |
| 00380740145279 | K060964 | 000 |
| 00380740190361 | K060964 | 000 |