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FDA 510(k)

i-STAT CG8+ cartridge with the i-STAT 1 System

K-Number: K223710 · 2023-07-28

ApplicantAbbott Point of Care, Inc.
Decision Date2023-07-28
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-STAT CG8+ cartridge with the i-STAT 1 System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K223710. 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 i-STAT CG8+ cartridge with the i-STAT 1 System?

i-STAT CG8+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K223710.

When did i-STAT CG8+ cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

i-STAT CG8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-07-28, under 510(k) number K223710.

Who is the listed applicant for i-STAT CG8+ cartridge with the i-STAT 1 System?

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

What is the FDA product code for i-STAT CG8+ cartridge with the i-STAT 1 System?

The FDA product code for i-STAT CG8+ cartridge with the i-STAT 1 System is CGA.

Other records listing Abbott Point of Care, 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.

K261039i-STAT Crea cartridge with the i-STAT 1 SystemK253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemK240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemK234143i-STAT TBI Cartridge with the i-STAT Alinity SystemK230300i-STAT CG8+ cartridge with the i-STAT 1 System

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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.K223090GEM Premier ChemSTATInstrumentation Laboratory CO

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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