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FDA 510(k)

Progenikine Concentrating System 25 mL System

K-Number: K191564 · 2019-11-07

ApplicantEmcyte Corporation
Decision Date2019-11-07
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Progenikine Concentrating System 25 mL System is a medical device manufactured by Emcyte Corporation. It received FDA 510(k) clearance on 2019-11-07 under approval number K191564. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Progenikine Concentrating System 25 mL System?

Progenikine Concentrating System 25 mL System is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by Emcyte Corporation. The 510(k) number is K191564.

When was Progenikine Concentrating System 25 mL System approved by the FDA?

Progenikine Concentrating System 25 mL System received FDA 510(k) clearance on 2019-11-07, under approval number K191564.

What company makes Progenikine Concentrating System 25 mL System?

Progenikine Concentrating System 25 mL System is manufactured by Emcyte Corporation.

What is the FDA product code for Progenikine Concentrating System 25 mL System?

The FDA product code for Progenikine Concentrating System 25 mL System is MUU.

Related Clinical Trials

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Other Devices by Emcyte Corporation

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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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