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FDA 510(k)

Capture-CMV

K-Number: K203612 · 2021-03-22

ApplicantImmucor, Inc.
Decision Date2021-03-22
Product CodeLJO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Capture-CMV is a medical device manufactured by Immucor, Inc.. It received FDA 510(k) clearance on 2021-03-22 under approval number K203612. The device is classified under product code LJO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capture-CMV?

Capture-CMV is a medical device that received FDA 510(k) clearance on 2021-03-22. It is manufactured by Immucor, Inc.. The 510(k) number is K203612.

When was Capture-CMV approved by the FDA?

Capture-CMV received FDA 510(k) clearance on 2021-03-22, under approval number K203612.

What company makes Capture-CMV?

Capture-CMV is manufactured by Immucor, Inc..

What is the FDA product code for Capture-CMV?

The FDA product code for Capture-CMV is LJO.

Other Devices by Immucor, Inc.

Related Devices (Code: LJO)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.