The following data is part of a premarket notification filed by Runbio Biotech Co.,ltd with the FDA for David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette.
| Device ID | K172627 |
| 510k Number | K172627 |
| Device Name: | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Runbio BioTech Co.,Ltd Rongsheng Technology Garden, Shantou University Road Shantou, CN 515063 |
| Contact | Chandler Chen |
| Correspondent | Chandler Chen Runbio BioTech Co.,Ltd Rongsheng Technology Garden, Shantou University Road Shantou, CN 515063 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2018-03-28 |
| Summary: | summary |