WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream— 510(k) K190705
Substantially EquivalentWholepower Biotech Co., Ltd.
FDA 510(k) clearance K190705 for WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream, Substantially Equivalent on 2019-04-15. Applicant: Wholepower Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Wholepower 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.