The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Modification To Triage B-type Natriuretic Peptide (bnp) Test.
| Device ID | K032235 |
| 510k Number | K032235 |
| Device Name: | MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST |
| Classification | Test, Natriuretic Peptide |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | Jeffrey R Dahlen |
| Correspondent | Jeffrey R Dahlen BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2004-01-28 |
| Summary: | summary |