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FDA 510(k)

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

K-Number: K251221 · 2025-09-17

ApplicantAbbott
Decision Date2025-09-17
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) is a medical device manufactured by Abbott. It received FDA 510(k) clearance on 2025-09-17 under approval number K251221. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)?

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) is a medical device that received FDA 510(k) clearance on 2025-09-17. It is manufactured by Abbott. The 510(k) number is K251221.

When was Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) approved by the FDA?

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) received FDA 510(k) clearance on 2025-09-17, under approval number K251221.

What company makes Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)?

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) is manufactured by Abbott.

What is the FDA product code for Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)?

The FDA product code for Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) is MXD.

Related Clinical Trials

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Related PubMed Literature

PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

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Related Devices (Code: MXD)

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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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