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FDA 510(k)

ANAM Test System

K-Number: K201376 · 2021-03-25

ApplicantVista Lifesciences, Inc.
Decision Date2021-03-25
Product CodePOM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ANAM Test System is a medical device manufactured by Vista Lifesciences, Inc.. It received FDA 510(k) clearance on 2021-03-25 under approval number K201376. The device is classified under product code POM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANAM Test System?

ANAM Test System is a medical device that received FDA 510(k) clearance on 2021-03-25. It is manufactured by Vista Lifesciences, Inc.. The 510(k) number is K201376.

When was ANAM Test System approved by the FDA?

ANAM Test System received FDA 510(k) clearance on 2021-03-25, under approval number K201376.

What company makes ANAM Test System?

ANAM Test System is manufactured by Vista Lifesciences, Inc..

What is the FDA product code for ANAM Test System?

The FDA product code for ANAM Test System is POM.

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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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