Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream— 510(k) K183097
Substantially EquivalentWeihai Kangzhou Biotechnology Engineering Co., Ltd.
FDA 510(k) clearance K183097 for Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream, Substantially Equivalent on 2019-01-10. Applicant: Weihai Kangzhou Biotechnology Engineering Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Weihai Kangzhou Biotechnology Engineering 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
- Weihai City, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.