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FDA 510(k)

i-Stat Alinity System with i-Stat Glucose test

K-Number: K163271 · 2017-04-10

ApplicantAbbott Point of Care, Inc.
Decision Date2017-04-10
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-Stat Alinity System with i-Stat Glucose test 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 2017-04-10 under 510(k) number K163271. 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 Alinity System with i-Stat Glucose test?

i-Stat Alinity System with i-Stat Glucose test is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K163271.

When did i-Stat Alinity System with i-Stat Glucose test receive FDA 510(k) clearance?

i-Stat Alinity System with i-Stat Glucose test received FDA 510(k) clearance on 2017-04-10, under 510(k) number K163271.

Who is the listed applicant for i-Stat Alinity System with i-Stat Glucose test?

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 Alinity System with i-Stat Glucose test?

The FDA product code for i-Stat Alinity System with i-Stat Glucose test 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.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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