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FDA 510(k)

i-STAT G3+ cartridge with the i-STAT 1 System

K-Number: K223857 · 2023-09-15

ApplicantAbbott Point of Care, Inc.
Decision Date2023-09-15
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-STAT G3+ 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 2023-09-15 under approval number K223857. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-STAT G3+ cartridge with the i-STAT 1 System?

i-STAT G3+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Abbott Point of Care, Inc.. The 510(k) number is K223857.

When was i-STAT G3+ cartridge with the i-STAT 1 System approved by the FDA?

i-STAT G3+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-09-15, under approval number K223857.

What company makes i-STAT G3+ cartridge with the i-STAT 1 System?

i-STAT G3+ cartridge with the i-STAT 1 System is manufactured by Abbott Point of Care, Inc..

What is the FDA product code for i-STAT G3+ cartridge with the i-STAT 1 System?

The FDA product code for i-STAT G3+ cartridge with the i-STAT 1 System is CHL.

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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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