The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Cardiac Controls, Triage Troponin-i Control, Triage Ck-mb Control, Triage Myoglobin Control.
| Device ID | K974461 |
| 510k Number | K974461 |
| Device Name: | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| 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 | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1997-12-10 |