The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Tox Drug Screen.
| Device ID | K043242 |
| 510k Number | K043242 |
| Device Name: | TRIAGE TOX DRUG SCREEN |
| Classification | Colorimetry, Acetaminophen |
| 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 | LDP |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXO |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-23 |
| Decision Date | 2005-02-28 |
| Summary: | summary |