Cleared Traditional

Capture-CMV

K183571 · Immucor, Inc. · Microbiology

Feb 2019

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K183571 is an FDA 510(k) clearance for the Capture-CMV, a Antigen, Iha, Cytomegalovirus (Class II — Special Controls, product code LJO), submitted by Immucor, Inc. (Norcross, US). The FDA issued a Cleared decision on February 4, 2019, 45 days after receiving the submission on December 21, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number	K183571 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2018
Decision Date	February 04, 2019
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF