HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream— 510(k) K192123
Substantially EquivalentQingdao Hightop Biotech Co., Ltd.
FDA 510(k) clearance K192123 for HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream, Substantially Equivalent on 2019-09-05. Applicant: Qingdao Hightop Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Qingdao Hightop 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
- Qingdao, CN
Recent devices under product code LCX
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More clearances from Qingdao Hightop Biotech Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.