The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Profiler S.o.b. Panel.
| Device ID | K040437 |
| 510k Number | K040437 |
| Device Name: | TRIAGE PROFILER S.O.B. PANEL |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| 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 | DAP |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHX |
| Subsequent Product Code | MMI |
| Subsequent Product Code | NBC |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-19 |
| Decision Date | 2004-06-25 |
| Summary: | summary |