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FDA 510(k)

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

K-Number: K190088 · 2019-04-17

ApplicantInova Diagnostics, Inc.
Decision Date2019-04-17
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-04-17 under approval number K190088. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents?

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K190088.

When was QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents approved by the FDA?

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents received FDA 510(k) clearance on 2019-04-17, under approval number K190088.

What company makes QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents?

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents?

The FDA product code for QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents is DHR.

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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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