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FDA 510(k)

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

K-Number: K183680 · 2020-02-28

ApplicantAbbott Point of Care, Inc.
Decision Date2020-02-28
Product CodeJPI
Advisory CommitteeHE
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 2020-02-28 under approval number K183680. The device is classified under product code JPI. It was reviewed by the HE 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 2020-02-28. It is manufactured by Abbott Point of Care, Inc.. The 510(k) number is K183680.

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 2020-02-28, under approval number K183680.

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 JPI.

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Related Devices (Code: JPI)

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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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