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FDA 510(k)

Multichem A1c

K-Number: K162514 · 2016-10-26

ApplicantTechnopath Manufacturing
Decision Date2016-10-26
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Multichem A1c is a medical device manufactured by Technopath Manufacturing. It received FDA 510(k) clearance on 2016-10-26 under approval number K162514. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multichem A1c?

Multichem A1c is a medical device that received FDA 510(k) clearance on 2016-10-26. It is manufactured by Technopath Manufacturing. The 510(k) number is K162514.

When was Multichem A1c approved by the FDA?

Multichem A1c received FDA 510(k) clearance on 2016-10-26, under approval number K162514.

What company makes Multichem A1c?

Multichem A1c is manufactured by Technopath Manufacturing.

What is the FDA product code for Multichem A1c?

The FDA product code for Multichem A1c is JJX.

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Official Source

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