The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Acs:180 And Advia Centaur B-type Natriuretic Peptide (bnp) Assays.
| Device ID | K043228 |
| 510k Number | K043228 |
| Device Name: | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS |
| Classification | Test, Natriuretic Peptide |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Carol Bianca |
| Correspondent | Carol Bianca BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-22 |
| Decision Date | 2005-04-22 |
| Summary: | summary |