The following data is part of a premarket notification filed by Tianjin New Bay Bioresearch Co., Ltd. with the FDA for Quikresponse One Step Midstream Early Pregrancy Test.
| Device ID | K112449 |
| 510k Number | K112449 |
| Device Name: | QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Tianjin New Bay Bioresearch Co., Ltd. 5230 VIA PRIMARIA Yorba Linda, CA 92886 |
| Contact | Hann-ping Wang |
| Correspondent | Hann-ping Wang Tianjin New Bay Bioresearch Co., Ltd. 5230 VIA PRIMARIA Yorba Linda, CA 92886 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-25 |
| Decision Date | 2012-09-24 |
| Summary: | summary |