Capture-CMV— 510(k) K183571

Substantially Equivalent

Immucor, Inc.

FDA 510(k) clearance K183571 for Capture-CMV, Substantially Equivalent on 2019-02-04. Applicant: Immucor, Inc.. Device class: 2.

Clearance details

Applicant: Immucor, Inc.
Product code: Code LJO
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 2018-12-21
Decision date: 2019-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.