The following data is part of a premarket notification filed by Healstone Biotech Inc. with the FDA for Hcg One Step Pregnancy Test.
| Device ID | K212418 |
| 510k Number | K212418 |
| Device Name: | HCG One Step Pregnancy Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Healstone Biotech Inc. Unit 650, 655 West Kent Ave. N., Vancouver, CA V6P 6 |
| Contact | Guang Gao |
| Correspondent | Guang Gao Axteria Biomed Consulting 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 | 2021-08-03 |
| Decision Date | 2022-06-30 |