Unifi Workspace v1.0.0
K-Number: K190694 · 2019-07-11
ApplicantHologic, Inc.
Decision Date2019-07-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Unifi Workspace v1.0.0 is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2019-07-11 under approval number K190694. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Unifi Workspace v1.0.0?
Unifi Workspace v1.0.0 is a medical device that received FDA 510(k) clearance on 2019-07-11. It is manufactured by Hologic, Inc.. The 510(k) number is K190694.
When was Unifi Workspace v1.0.0 approved by the FDA?
Unifi Workspace v1.0.0 received FDA 510(k) clearance on 2019-07-11, under approval number K190694.
What company makes Unifi Workspace v1.0.0?
Unifi Workspace v1.0.0 is manufactured by Hologic, Inc..
What is the FDA product code for Unifi Workspace v1.0.0?
The FDA product code for Unifi Workspace v1.0.0 is LLZ.
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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.