The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Drugs Of Abuse Panel Plus Ppx, Model Catalog 92002.
| Device ID | K014247 |
| 510k Number | K014247 |
| Device Name: | TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | Jeffrey R Dahlen |
| Correspondent | Jeffrey R Dahlen BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-26 |
| Decision Date | 2002-06-03 |
| Summary: | summary |