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FDA 510(k)

i-STAT Hematocrit test with i-STAT Alinity System

K-Number: K163342 · 2017-08-22

ApplicantAbbott Laboratories
Decision Date2017-08-22
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

i-STAT Hematocrit test with i-STAT Alinity System is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2017-08-22 under approval number K163342. 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 Hematocrit test with i-STAT Alinity System?

i-STAT Hematocrit test with i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2017-08-22. It is manufactured by Abbott Laboratories. The 510(k) number is K163342.

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

i-STAT Hematocrit test with i-STAT Alinity System received FDA 510(k) clearance on 2017-08-22, under approval number K163342.

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

i-STAT Hematocrit test with i-STAT Alinity System is manufactured by Abbott Laboratories.

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

The FDA product code for i-STAT Hematocrit test with i-STAT Alinity System is JPI.

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Related Devices (Code: JPI)

K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott 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.

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