FDA 510(k)

Macroduct Advanced Model 3710

K-Number: K180627 · 2018-07-27

Decision Date2018-07-27

Product CodeKTB

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Macroduct Advanced Model 3710 is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup, Inc.. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K180627. The device is classified under product code KTB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Macroduct Advanced Model 3710?

Macroduct Advanced Model 3710 is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Elitechgroup, Inc.. The 510(k) number is K180627.

When did Macroduct Advanced Model 3710 receive FDA 510(k) clearance?

Macroduct Advanced Model 3710 received FDA 510(k) clearance on 2018-07-27, under 510(k) number K180627.

Who is the listed applicant for Macroduct Advanced Model 3710?

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

What is the FDA product code for Macroduct Advanced Model 3710?

The FDA product code for Macroduct Advanced Model 3710 is KTB.

Other records listing Elitechgroup, Inc. as applicant

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.

K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGenius K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

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.