Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream— 510(k) K150022
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K150022 for Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream, Substantially Equivalent on 2015-08-07. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.