Immucise
K-Number: K190427 · 2019-07-18
ApplicantTerumo Corporation
Decision Date2019-07-18
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Immucise is a medical device manufactured by Terumo Corporation. It received FDA 510(k) clearance on 2019-07-18 under approval number K190427. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Immucise?
Immucise is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Terumo Corporation. The 510(k) number is K190427.
When was Immucise approved by the FDA?
Immucise received FDA 510(k) clearance on 2019-07-18, under approval number K190427.
What company makes Immucise?
Immucise is manufactured by Terumo Corporation.
What is the FDA product code for Immucise?
The FDA product code for Immucise is FMF.
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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.