K051841 is an FDA 510(k) clearance for the WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on August 22, 2005, 46 days after receiving the submission on July 7, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K051841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2005 |
| Decision Date | August 22, 2005 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHI - Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |