Submission Details
| 510(k) Number | K162333 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Wondfo One Step Fecal Occult Blood (FOB) Test
May 2017
Decision
265d
Days
Class 2
Risk
About This 510(k) Submission
K162333 is an FDA 510(k) clearance for the Wondfo One Step Fecal Occult Blood (FOB) Test, 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 review panel. Regulated under 21 CFR 864.6550.
Device Classification
| Product Code | KHE — Reagent, Occult Blood |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.6550 |
Manufacturer
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