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FDA 510(k)

MediLab

K-Number: K221065 · 2022-06-10

ApplicantSigma Scientific Services, LLC
Decision Date2022-06-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MediLab is a medical device manufactured by Sigma Scientific Services, LLC. It received FDA 510(k) clearance on 2022-06-10 under approval number K221065. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MediLab?

MediLab is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Sigma Scientific Services, LLC. The 510(k) number is K221065.

When was MediLab approved by the FDA?

MediLab received FDA 510(k) clearance on 2022-06-10, under approval number K221065.

What company makes MediLab?

MediLab is manufactured by Sigma Scientific Services, LLC.

What is the FDA product code for MediLab?

The FDA product code for MediLab is LLZ.

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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.

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