The following data is part of a premarket notification filed by Sugentech, Inc. with the FDA for Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test.
| Device ID | K142754 |
| 510k Number | K142754 |
| Device Name: | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Sugentech, Inc. Daejeon Bioventure Town, 1662, Yuseong-daero, Yuseong-gu Daejeon, KR 305-811 |
| Contact | Mijin Sohn |
| Correspondent | Jiyoung Kwak Sugentech, Inc. Shinyoung Palace Tower, 21 Hwangsaeul-ro 360beon-gil Bundang-gu Seongnam, KR 463-824 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-25 |
| Decision Date | 2016-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809408860597 | K142754 | 000 |
| 08809408860191 | K142754 | 000 |