Cleared Traditional

CYTOMEGALOVIRUS ANTIBODY SCREEN

K910003 · Immucor, Inc. · Microbiology

Mar 1991

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K910003 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS ANTIBODY SCREEN, 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 20, 1991, 77 days after receiving the submission on January 2, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number	K910003 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 1991
Decision Date	March 20, 1991
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—