FDA 510(k)

Audit MicroControls Linearity FD Tumor Markers II

K-Number: K163629 · 2017-03-10

Decision Date2017-03-10

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Audit MicroControls Linearity FD Tumor Markers II is a medical device manufactured by Aalto Scientific, Ltd.. It received FDA 510(k) clearance on 2017-03-10 under approval number K163629. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Audit MicroControls Linearity FD Tumor Markers II?

Audit MicroControls Linearity FD Tumor Markers II is a medical device that received FDA 510(k) clearance on 2017-03-10. It is manufactured by Aalto Scientific, Ltd.. The 510(k) number is K163629.

When was Audit MicroControls Linearity FD Tumor Markers II approved by the FDA?

Audit MicroControls Linearity FD Tumor Markers II received FDA 510(k) clearance on 2017-03-10, under approval number K163629.

What company makes Audit MicroControls Linearity FD Tumor Markers II?

Audit MicroControls Linearity FD Tumor Markers II is manufactured by Aalto Scientific, Ltd..

What is the FDA product code for Audit MicroControls Linearity FD Tumor Markers II?

The FDA product code for Audit MicroControls Linearity FD Tumor Markers II is JJY.

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Related Devices (Code: JJY)

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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.