Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

i-STAT G cartridge with the i-STAT 1 System

K-Number: K223755 · 2023-09-11

ApplicantAbbott Point of Care, Inc.
Decision Date2023-09-11
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-STAT G 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 2023-09-11 under 510(k) number K223755. 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 G cartridge with the i-STAT 1 System?

i-STAT G cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-09-11. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K223755.

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

i-STAT G cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-09-11, under 510(k) number K223755.

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

The FDA product code for i-STAT G 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

View all 20 devices →

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.K223710i-STAT CG8+ 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.

↑