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FDA 510(k)

GEM Premier ChemSTAT

K-Number: K223090 · 2023-01-27

ApplicantInstrumentation Laboratory CO
Decision Date2023-01-27
Product CodeCGA
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 2023-01-27 under 510(k) number K223090. The device is classified under product code CGA. 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 2023-01-27. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K223090.

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

GEM Premier ChemSTAT received FDA 510(k) clearance on 2023-01-27, under 510(k) number K223090.

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 CGA.

Other records listing Instrumentation Laboratory CO as applicant

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Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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