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FDA 510(k)

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

K-Number: K232864 · 2024-01-26

ApplicantNantong Egens Biotechnology Co., Ltd.
Decision Date2024-01-26
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is a medical device manufactured by Nantong Egens Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-26 under approval number K232864. 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 EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is a medical device that received FDA 510(k) clearance on 2024-01-26. It is manufactured by Nantong Egens Biotechnology Co., Ltd.. The 510(k) number is K232864.

When was EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II approved by the FDA?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II received FDA 510(k) clearance on 2024-01-26, under approval number K232864.

What company makes EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is manufactured by Nantong Egens Biotechnology Co., Ltd..

What is the FDA product code for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

The FDA product code for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II 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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