The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Cardioprofiler And Profiler S.o.b. Panels.
| Device ID | K080269 |
| 510k Number | K080269 |
| Device Name: | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS |
| Classification | Test, Natriuretic Peptide |
| Applicant | BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Contact | Dawn A Allenby |
| Correspondent | Dawn A Allenby BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD San Diego, CA 92121 |
| Product Code | NBC |
| Subsequent Product Code | DAP |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHX |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-01 |
| Decision Date | 2008-06-06 |
| Summary: | summary |