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 |