The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Biosite Diagnostics - Triage Panel For Drugs Of Abuse Plus Tricyclic Antidepressants.
| Device ID | K934340 |
| 510k Number | K934340 |
| Device Name: | BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS |
| Classification | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs |
| 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 | LFI |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-08 |
| Decision Date | 1994-12-02 |