The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Tri-fect Drug Screen Test Device.
| Device ID | K041743 |
| 510k Number | K041743 |
| Device Name: | ACON TRI-FECT DRUG SCREEN TEST DEVICE |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. 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 | LAF |
| 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 | 2004-06-28 |
| Decision Date | 2004-09-09 |
| Summary: | summary |