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FDA 510(k)

Immucise Intradermal Injection System

K-Number: K181369 · 2018-11-13

ApplicantTerumo Corporation
Decision Date2018-11-13
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Immucise Intradermal Injection System is a medical device manufactured by Terumo Corporation. It received FDA 510(k) clearance on 2018-11-13 under approval number K181369. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Immucise Intradermal Injection System?

Immucise Intradermal Injection System is a medical device that received FDA 510(k) clearance on 2018-11-13. It is manufactured by Terumo Corporation. The 510(k) number is K181369.

When was Immucise Intradermal Injection System approved by the FDA?

Immucise Intradermal Injection System received FDA 510(k) clearance on 2018-11-13, under approval number K181369.

What company makes Immucise Intradermal Injection System?

Immucise Intradermal Injection System is manufactured by Terumo Corporation.

What is the FDA product code for Immucise Intradermal Injection System?

The FDA product code for Immucise Intradermal Injection System is FMI.

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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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