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FDA 510(k)

GEM Premier 7000 with IQM3

K-Number: K223608 · 2023-08-10

ApplicantInstrumentation Laboratory Company
Decision Date2023-08-10
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM Premier 7000 with IQM3 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory Company. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K223608. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM Premier 7000 with IQM3?

GEM Premier 7000 with IQM3 is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Instrumentation Laboratory Company. The 510(k) number is K223608.

When did GEM Premier 7000 with IQM3 receive FDA 510(k) clearance?

GEM Premier 7000 with IQM3 received FDA 510(k) clearance on 2023-08-10, under 510(k) number K223608.

Who is the listed applicant for GEM Premier 7000 with IQM3?

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

What is the FDA product code for GEM Premier 7000 with IQM3?

The FDA product code for GEM Premier 7000 with IQM3 is CHL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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