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FDA 510(k)

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream

K-Number: K200133 · 2020-08-13

ApplicantSafecare Biotech (Hangzhou) Co., Ltd.
Decision Date2020-08-13
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K200133. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream?

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K200133.

When did hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream receive FDA 510(k) clearance?

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream received FDA 510(k) clearance on 2020-08-13, under 510(k) number K200133.

Who is the listed applicant for hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream?

The FDA 510(k) record lists Safecare Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream?

The FDA product code for hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream is LCX.

Other records listing Safecare Biotech (Hangzhou) Co., Ltd. as applicant

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Related Devices (Code: LCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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