The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Advia Centaur B-type Natriuretic Peptide (bnp) Assay.
| Device ID | K031038 |
| 510k Number | K031038 |
| Device Name: | ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY |
| Classification | Test, Natriuretic Peptide |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| 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 | 2003-04-01 |
| Decision Date | 2003-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598024 | K031038 | 000 |
| 00630414598000 | K031038 | 000 |
| 00630414597980 | K031038 | 000 |
| 00630414472836 | K031038 | 000 |
| 00630414472829 | K031038 | 000 |
| 00630414472805 | K031038 | 000 |
| 00630414294032 | K031038 | 000 |
| 00630414472799 | K031038 | 000 |
| 00630414598017 | K031038 | 000 |