The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Statmeter.
| Device ID | K973547 |
| 510k Number | K973547 |
| Device Name: | TRIAGE STATMETER |
| Classification | Fluorometer, For Clinical Use |
| 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 | KHO |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHX |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1998-01-13 |