Wondfo One Step Fecal Occult Blood (FOB) Test— 510(k) K162333
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K162333 for Wondfo One Step Fecal Occult Blood (FOB) Test, Substantially Equivalent on 2017-05-14. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code KHE
view allMore clearances from Guangzhou Wondfo Biotech Co., Ltd.
view all- K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
- K251289 — WELLlife COVID-19 Antigen Test Rx
- K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- K241741 — SAFElife Fentanyl Urine Home Test (Cassette) +3 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.