K162333 is an FDA 510(k) clearance for the Wondfo One Step Fecal Occult Blood (FOB) Test. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 14, 2017, 265 days after receiving the submission on August 22, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K162333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2016 |
| Decision Date | May 14, 2017 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KHE — Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |