Cleared Traditional

COPALIS CMV TOTAL ANTIBODY ASSAY

K955799 · Sienna Biotech, Inc. · Microbiology

Jul 1996

Decision

201d

Days

Class 2

Risk

About This 510(k) Submission

K955799 is an FDA 510(k) clearance for the COPALIS CMV TOTAL ANTIBODY ASSAY, a Antigen, Iha, Cytomegalovirus (Class II — Special Controls, product code LJO), submitted by Sienna Biotech, Inc. (Bethesda, US). The FDA issued a Cleared decision on July 10, 1996, 201 days after receiving the submission on December 22, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number	K955799 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 1995
Decision Date	July 10, 1996
Days to Decision	201 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF