The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Biosite Diagnostics-triage Panel For Drugs Abuse.
| Device ID | K914146 |
| 510k Number | K914146 |
| Device Name: | BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-16 |
| Decision Date | 1991-10-11 |