The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Biosite Diagnostics Opiate Screening Test.
| Device ID | K902924 |
| 510k Number | K902924 |
| Device Name: | BIOSITE DIAGNOSTICS OPIATE SCREENING TEST |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | Kim Blickenstaff |
| Correspondent | Kim Blickenstaff BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-02 |
| Decision Date | 1990-09-14 |