The following data is part of a premarket notification filed by Runbio Biotech Co.,ltd with the FDA for David One Step Home Use Pregnancy Test Midstream, David One Step Home Use Pregnancy Test Strip, David One Step Prescription Pregnancy Test Strip, David One Step Prescription Pregnancy Test Cassette, David One Step Home Use Pregnancy Test Cassette.
| Device ID | K181551 |
| 510k Number | K181551 |
| Device Name: | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Runbio BioTech Co.,Ltd Rongsheng Technological Zone, University Road Shantou, CN 515063 |
| Contact | Lyn Chen |
| Correspondent | Lyn Chen Runbio BioTech Co.,Ltd Rongsheng Technological Zone, 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 | 2018-06-13 |
| Decision Date | 2019-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938444982207 | K181551 | 000 |
| 06938444982191 | K181551 | 000 |
| 06938444982184 | K181551 | 000 |
| 00860001730203 | K181551 | 000 |
| 00850014758363 | K181551 | 000 |
| 06938444982269 | K181551 | 000 |
| 00850035206003 | K181551 | 000 |