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FDA 510(k)

i-STAT CHEM8+ cartridge with the i-STAT 1 System

K-Number: K210958 · 2021-08-13

ApplicantAbbott Point of Care, Inc.
Decision Date2021-08-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-STAT CHEM8+ 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 2021-08-13 under approval number K210958. 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 CHEM8+ cartridge with the i-STAT 1 System?

i-STAT CHEM8+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Abbott Point of Care, Inc.. The 510(k) number is K210958.

When was i-STAT CHEM8+ cartridge with the i-STAT 1 System approved by the FDA?

i-STAT CHEM8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2021-08-13, under approval number K210958.

What company makes i-STAT CHEM8+ cartridge with the i-STAT 1 System?

i-STAT CHEM8+ cartridge with the i-STAT 1 System is manufactured by Abbott Point of Care, Inc..

What is the FDA product code for i-STAT CHEM8+ cartridge with the i-STAT 1 System?

The FDA product code for i-STAT CHEM8+ cartridge with the i-STAT 1 System is CGA.

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Related Devices (Code: CGA)

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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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