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

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 a medical device manufactured by Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2023-07-28 under approval 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. It is manufactured by Abbott Point of Care, Inc.. The 510(k) number is K223710.

When was i-STAT CG8+ cartridge with the i-STAT 1 System approved by the FDA?

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

What company makes i-STAT CG8+ cartridge with the i-STAT 1 System?

i-STAT CG8+ cartridge with the i-STAT 1 System is manufactured by Abbott Point of Care, Inc..

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.

Related Clinical Trials

NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT03836482 Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD RECRUITING

Other Devices by Abbott Point of Care, Inc.

K153357i-STAT Alinity System with i-STAT Sodium test K163271i-Stat Alinity System with i-Stat Glucose test K200492i-STAT CG4+ Cartridge with the i-STAT 1 System K183680i-STAT CHEM8+ cartridge with the i-STAT 1 System K191360i-STAT CHEM8+ cartridge with the i-STAT 1 System K183678i-STAT CHEM8+ cartridge with the i-STAT 1 System

View all 17 devices →

Related Devices (Code: CGA)

K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO K161818GEM Premier 3000Instrumentation Laboratory CO K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerInfrared Laboratory Systems, LLC (Dba Synermed) K163433VITROS Chemistry Products GLU SlidesOrtho Clinical Diagnostics K163271i-Stat Alinity System with i-Stat Glucose testAbbott 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.

↑