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FDA 510(k) K193132 — CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
FDA 510(k) index record K193132. Device: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd.. Decision date: 2019-12-11.
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"device_name": "CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K193132.
Device name: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd..
Decision date: 2019-12-11. 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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