SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream— 510(k) K212447
Substantially EquivalentHangzhou Sejoy Electronics & Instruments Co., Ltd.
FDA 510(k) clearance K212447 for SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream, Substantially Equivalent on 2022-02-18. Applicant: Hangzhou Sejoy Electronics & Instruments Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Sejoy Electronics & Instruments Co., Ltd.
- Product code
- Product 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 City, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.