K043443 is an FDA 510(k) clearance for the ONE STEP HCG URINE PREGNANCY TEST. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Yardley, US). The FDA issued a Cleared decision on April 8, 2005, 115 days after receiving the submission on December 14, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K043443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2004 |
| Decision Date | April 08, 2005 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |