INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream— 510(k) K192843
Substantially EquivalentInnovita (Tangshan) Biological Technology Co., Ltd.
FDA 510(k) clearance K192843 for INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream, Substantially Equivalent on 2019-11-22. Applicant: Innovita (Tangshan) Biological Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Innovita (Tangshan) Biological Technology 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
- Qian'An, CN
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More clearances from Innovita (Tangshan) Biological Technology Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.