The following data is part of a premarket notification filed by True Diagnostics, Inc. with the FDA for Vericlear Digital Early Result Pregnancy Test.
| Device ID | K182328 |
| 510k Number | K182328 |
| Device Name: | VeriClear Digital Early Result Pregnancy Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | True Diagnostics, Inc. 2782 Loker Ave West Carlsbad, CA 92010 |
| Contact | Jerry Lee |
| Correspondent | Jinjie Hu Axteria BioMed Consulting Inc. 8040 Cobble Creek Circle Potomac, MD 20854 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-27 |
| Decision Date | 2019-05-15 |
| Summary: | summary |