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FDA 510(k)

GEM Premier 5000

K-Number: K203790 · 2021-08-20

ApplicantInstrumentation Laboratory CO
Decision Date2021-08-20
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM Premier 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K203790. 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 5000?

GEM Premier 5000 is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K203790.

When did GEM Premier 5000 receive FDA 510(k) clearance?

GEM Premier 5000 received FDA 510(k) clearance on 2021-08-20, under 510(k) number K203790.

Who is the listed applicant for GEM Premier 5000?

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

What is the FDA product code for GEM Premier 5000?

The FDA product code for GEM Premier 5000 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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