The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Cardiac Controls; Triage Cardio Profiler Controls.
| Device ID | K030089 |
| 510k Number | K030089 |
| Device Name: | TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-10 |
| Decision Date | 2003-01-23 |
| Summary: | summary |