The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Opi One Step Opiates Test Strip, Acon Opi One Step Opiates Test Device.
| Device ID | K011353 |
| 510k Number | K011353 |
| Device Name: | ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ACON LABORATORIES, INC. 4104 SORRENTO VALLY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung ACON LABORATORIES, INC. 4104 SORRENTO VALLY BLVD. San Diego, CA 92121 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-03 |
| Decision Date | 2001-07-30 |