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FDA 510(k) K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

FDA 510(k) index record K242135. Device: Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream. Applicant as listed: Nanjing Synthgene Medical Technology Co., Ltd.. Decision date: 2025-01-31.

OtherU.S. Food and Drug Administration (FDA)2025-01-31

Fuente

"device_name": "Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-25

Disclaimer

professional use

References

FDA 510(k) public index record K242135.

Device name: Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream. Applicant as listed: Nanjing Synthgene Medical Technology Co., Ltd..

Decision date: 2025-01-31. Decision wording: Substantially Equivalent.

Product code: LCX. Regulation: 21 CFR 862.1155. Medical specialty: Clinical Chemistry.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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