The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon One Step Multi-drug Multi-line Screen Test Card, Acon One Step Multi-drug Multi-line Screen Test Device.
| Device ID | K023946 |
| 510k Number | K023946 |
| Device Name: | ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-27 |
| Decision Date | 2003-02-05 |
| Summary: | summary |