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FDA 510(k)

Alinity c ICT Sample Diluent

K-Number: K170320 · 2017-10-24

ApplicantAbbott Laboratories
Decision Date2017-10-24
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Alinity c ICT Sample Diluent is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2017-10-24 under 510(k) number K170320. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity c ICT Sample Diluent?

Alinity c ICT Sample Diluent is a medical device that received FDA 510(k) clearance on 2017-10-24. The listed applicant is Abbott Laboratories. The 510(k) number is K170320.

When did Alinity c ICT Sample Diluent receive FDA 510(k) clearance?

Alinity c ICT Sample Diluent received FDA 510(k) clearance on 2017-10-24, under 510(k) number K170320.

Who is the listed applicant for Alinity c ICT Sample Diluent?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alinity c ICT Sample Diluent?

The FDA product code for Alinity c ICT Sample Diluent is CGZ.

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Official Source

View on FDA Database →

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