FDA 510(k)

Multichem A1c

K-Number: K162514 · 2016-10-26

Decision Date2016-10-26

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Multichem A1c is the device name listed in this FDA 510(k) record. The listed applicant is Technopath Manufacturing. It received FDA 510(k) clearance on 2016-10-26 under 510(k) 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. The listed applicant is Technopath Manufacturing. The 510(k) number is K162514.

When did Multichem A1c receive FDA 510(k) clearance?

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

Who is the listed applicant for Multichem A1c?

The FDA 510(k) record lists Technopath Manufacturing as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multichem A1c?

The FDA product code for Multichem A1c is JJX.

Related Devices (Code: JJX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.