FDA 510(k)

FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream

K-Number: K233174 · 2024-02-05

ApplicantAssure Tech. (Hangzhou) Co, Ltd.

Decision Date2024-02-05

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream is a medical device manufactured by Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2024-02-05 under approval number K233174. 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 FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream?

FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2024-02-05. It is manufactured by Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K233174.

When was FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream approved by the FDA?

FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2024-02-05, under approval number K233174.

What company makes FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream?

FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream is manufactured by Assure Tech. (Hangzhou) Co, Ltd..

What is the FDA product code for FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream?

The FDA product code for FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream is LCX.

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Related Devices (Code: LCX)

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Official Source

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