Cleared Traditional

ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY

K951851 · E.I. Dupont DE Nemours & Co., Inc. · Microbiology

Jul 1996

Decision

460d

Days

Class 2

Risk

About This 510(k) Submission

K951851 is an FDA 510(k) clearance for the ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY, a Antigen, Iha, Cytomegalovirus (Class II — Special Controls, product code LJO), submitted by E.I. Dupont DE Nemours & Co., Inc. (Newark, US). The FDA issued a Cleared decision on July 24, 1996, 460 days after receiving the submission on April 21, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number	K951851 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 1995
Decision Date	July 24, 1996
Days to Decision	460 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement