The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Phencyclidine Urine Test, Tricyclic Antidepressants Urine Test.
| Device ID | K112395 |
| 510k Number | K112395 |
| Device Name: | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST |
| Classification | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE SUITE F Gaithersburg, MD 20878 |
| Contact | Joe Shia |
| Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE SUITE F Gaithersburg, MD 20878 |
| Product Code | LFG |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-19 |
| Decision Date | 2011-09-09 |
| Summary: | summary |