The following data is part of a De Novo classification by Biosite Incorporated with the FDA for Triage B-type Natriuretic Peptide (bnp) Test.
| DeNovo ID | DEN000010 |
| Device Name: | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST |
| Classification | Test, Natriuretic Peptide |
| Applicant | BIOSITE INCORPORATED 11030 Roselle St. San Diego, CA 92121 |
| Contact | Jeff Dahlen |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K003475 |
| Review Advisory Board | Clinical Chemistry |
| Classification Advisory | Clinical Chemistry |
| Type | Post-NSE |
| Date Received | 2000-11-15 |
| Decision Date | 2000-11-20 |
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