The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon One Step Drug Screen Test Card.
| Device ID | K020771 |
| 510k Number | K020771 |
| Device Name: | ACON ONE STEP DRUG SCREEN TEST CARD |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DPK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-08 |
| Decision Date | 2002-05-15 |
| Summary: | summary |