Source document or public record
FDA 510(k) K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
FDA 510(k) index record K200133. Device: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd.. Decision date: 2020-08-13.
Source
"device_name": "hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K200133.
Device name: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd..
Decision date: 2020-08-13. 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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