The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Cardio Profiler/triage Cardiac Panel.
| Device ID | K030286 |
| 510k Number | K030286 |
| Device Name: | TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL |
| 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 |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHX |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-28 |
| Decision Date | 2003-02-21 |
| Summary: | summary |