The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Tca One Step Tricyclic Antidepressant Test Strip And Device.
| Device ID | K021526 |
| 510k Number | K021526 |
| Device Name: | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE |
| Classification | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| 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 | LFG |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-07-17 |
| Summary: | summary |