The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage(r) Cardiac Panel Calibration Verification Controls, Triag (r) Myoglobin Calibration Verification Controls, Triage.
| Device ID | K974827 |
| 510k Number | K974827 |
| Device Name: | TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | John F Bruni |
| Correspondent | John F Bruni 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 | 1997-12-24 |
| Decision Date | 1998-01-08 |