The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for One Step Hcg Urine/serum Test.
| Device ID | K072500 |
| 510k Number | K072500 |
| Device Name: | ONE STEP HCG URINE/SERUM TEST |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley, PA 19067 |
| Contact | Howard Mann |
| Correspondent | Howard Mann Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley, PA 19067 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-05 |
| Decision Date | 2009-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816862021639 | K072500 | 000 |