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FDA 510(k)

i-STAT Alinity System with i-STAT Sodium test

K-Number: K153357 · 2016-07-08

ApplicantAbbott Point of Care, Inc.
Decision Date2016-07-08
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-STAT Alinity System with i-STAT Sodium test is a medical device manufactured by Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2016-07-08 under approval number K153357. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-STAT Alinity System with i-STAT Sodium test?

i-STAT Alinity System with i-STAT Sodium test is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Abbott Point of Care, Inc.. The 510(k) number is K153357.

When was i-STAT Alinity System with i-STAT Sodium test approved by the FDA?

i-STAT Alinity System with i-STAT Sodium test received FDA 510(k) clearance on 2016-07-08, under approval number K153357.

What company makes i-STAT Alinity System with i-STAT Sodium test?

i-STAT Alinity System with i-STAT Sodium test is manufactured by Abbott Point of Care, Inc..

What is the FDA product code for i-STAT Alinity System with i-STAT Sodium test?

The FDA product code for i-STAT Alinity System with i-STAT Sodium test is JGS.

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Related Devices (Code: JGS)

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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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