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FDA 510(k)

CELL-DYN Emerald 22 AL System

K-Number: K190294 · 2019-03-15

ApplicantAbbott Laboratories
Decision Date2019-03-15
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN Emerald 22 AL System is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2019-03-15 under approval number K190294. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL-DYN Emerald 22 AL System?

CELL-DYN Emerald 22 AL System is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Abbott Laboratories. The 510(k) number is K190294.

When was CELL-DYN Emerald 22 AL System approved by the FDA?

CELL-DYN Emerald 22 AL System received FDA 510(k) clearance on 2019-03-15, under approval number K190294.

What company makes CELL-DYN Emerald 22 AL System?

CELL-DYN Emerald 22 AL System is manufactured by Abbott Laboratories.

What is the FDA product code for CELL-DYN Emerald 22 AL System?

The FDA product code for CELL-DYN Emerald 22 AL System is GKZ.

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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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