The following data is part of a premarket notification filed by Acro Biotech, Inc. with the FDA for Acro Hcg Pregnancy Rapid Test.
| Device ID | K180771 |
| 510k Number | K180771 |
| Device Name: | Acro HCG Pregnancy Rapid Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ACRO Biotech, Inc. 9500 Seventh Street, Suite M Rancho Cucamonga, CA 91730 |
| Contact | Joseph Fan |
| Correspondent | Feng-yu Lee IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2018-05-18 |
| Summary: | summary |