Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Capture-CMV

K-Number: K183571 · 2019-02-04

ApplicantImmucor, Inc.
Decision Date2019-02-04
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 2019-02-04 under approval number K183571. 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 2019-02-04. It is manufactured by Immucor, Inc.. The 510(k) number is K183571.

When was Capture-CMV approved by the FDA?

Capture-CMV received FDA 510(k) clearance on 2019-02-04, under approval number K183571.

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

View on FDA Database →

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