Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream— 510(k) K242135
Substantially EquivalentNanjing Synthgene Medical Technology Co., Ltd.
FDA 510(k) clearance K242135 for Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream, Substantially Equivalent on 2025-01-31. Applicant: Nanjing Synthgene Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Nanjing Synthgene Medical 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
- Nanjing, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.