The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Panel For Drugs Of Abuse Model 9500/93000.
| Device ID | K955934 |
| 510k Number | K955934 |
| Device Name: | TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 |
| 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 |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-13 |
| Decision Date | 1996-02-16 |