K041273 is an FDA 510(k) clearance for the ONE-STEP PREGNANCY TEST. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on May 20, 2004, 8 days after receiving the submission on May 12, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K041273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2004 |
| Decision Date | May 20, 2004 |
| Days to Decision | 8 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 |