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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 a medical device manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-08-13 under approval 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. It is manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K200133.

When was hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream approved by the FDA?

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

What company makes 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 manufactured by Safecare Biotech (Hangzhou) Co., Ltd..

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.

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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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