The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Cardiac Panel, Triage Troponin-i, Triage Ck-mb, Triage Myoglobin, Triage Troponin-i And Ck-mb, Triage Troponin-i.
| Device ID | K973126 |
| 510k Number | K973126 |
| Device Name: | TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| 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 | JHX |
| Subsequent Product Code | DDR |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-20 |
| Decision Date | 1997-10-06 |