The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for One Step Hcg Urine Pregnancy Test.
| Device ID | K043443 |
| 510k Number | K043443 |
| Device Name: | ONE STEP HCG URINE PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley, PA 19087 |
| Contact | Howard Mann |
| Correspondent | Howard Mann Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley, PA 19087 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-14 |
| Decision Date | 2005-04-08 |
| Summary: | summary |