The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Biosite Triage Panel For Drugs Of Abuse(50ng/ml).
| Device ID | K931598 |
| 510k Number | K931598 |
| Device Name: | BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML) |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | Bruni, Ph.d. |
| Correspondent | Bruni, Ph.d. BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-01 |
| Decision Date | 1993-05-12 |