Cleared Traditional

Capture-CMV

K203612 · Immucor, Inc. · Microbiology

Mar 2021

Decision

102d

Days

Class 2

Risk

About This 510(k) Submission

K203612 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 March 22, 2021, 102 days after receiving the submission on December 10, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number	K203612 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2020
Decision Date	March 22, 2021
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF