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FDA 510(k)

ACESO Early Pregnancy Test

K-Number: K234152 · 2024-04-05

ApplicantAceso Laboratories, Inc.
Decision Date2024-04-05
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACESO Early Pregnancy Test is a medical device manufactured by Aceso Laboratories, Inc.. It received FDA 510(k) clearance on 2024-04-05 under approval number K234152. 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 ACESO Early Pregnancy Test?

ACESO Early Pregnancy Test is a medical device that received FDA 510(k) clearance on 2024-04-05. It is manufactured by Aceso Laboratories, Inc.. The 510(k) number is K234152.

When was ACESO Early Pregnancy Test approved by the FDA?

ACESO Early Pregnancy Test received FDA 510(k) clearance on 2024-04-05, under approval number K234152.

What company makes ACESO Early Pregnancy Test?

ACESO Early Pregnancy Test is manufactured by Aceso Laboratories, Inc..

What is the FDA product code for ACESO Early Pregnancy Test?

The FDA product code for ACESO Early Pregnancy Test 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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