The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo One Step Hcg Urine Pregnancy Test Strip, Wondfo One Step Hcg Urine Pregnancy Test Cassette, Wondfo One Step Hcg Urine Pregnancy Test Midstream.
| Device ID | K150022 |
| 510k Number | K150022 |
| Device Name: | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. Wondfo Scientech Park, South China Univ. Of Technology Guangzhou, CN 510641 |
| Contact | Ben Chen |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20878 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-06 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816862021513 | K150022 | 000 |
| 00032251057663 | K150022 | 000 |
| 10816862022176 | K150022 | 000 |
| 00846036009446 | K150022 | 000 |
| 00860000599634 | K150022 | 000 |
| 50096295141509 | K150022 | 000 |
| 50096295141516 | K150022 | 000 |
| 50096295141523 | K150022 | 000 |
| 50096295141530 | K150022 | 000 |
| 00049696128032 | K150022 | 000 |
| 00850029375029 | K150022 | 000 |
| 00850029375043 | K150022 | 000 |
| 00049696737739 | K150022 | 000 |
| 00860000599610 | K150022 | 000 |
| 00032251056192 | K150022 | 000 |