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FDA 510(k)

GEM Premier ChemSTAT

K-Number: K183555 · 2019-02-16

ApplicantInstrumentation Laboratory CO
Decision Date2019-02-16
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM Premier ChemSTAT 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 2019-02-16 under 510(k) number K183555. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM Premier ChemSTAT?

GEM Premier ChemSTAT is a medical device that received FDA 510(k) clearance on 2019-02-16. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K183555.

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

GEM Premier ChemSTAT received FDA 510(k) clearance on 2019-02-16, under 510(k) number K183555.

Who is the listed applicant for GEM Premier ChemSTAT?

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 ChemSTAT?

The FDA product code for GEM Premier ChemSTAT is JFY.

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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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