CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream— 510(k) K193132
Substantially EquivalentHangzhou Clongene Biotech Co., Ltd.
FDA 510(k) clearance K193132 for CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream, Substantially Equivalent on 2019-12-11. Applicant: Hangzhou Clongene Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Clongene 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
- Hangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.