Cleared Traditional

COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS

K961784 · Sienna Biotech, Inc. · Microbiology

Oct 1996

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K961784 is an FDA 510(k) clearance for the COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS, a Latex Agglutination Assay, Rubella (Class II — Special Controls, product code LQN), submitted by Sienna Biotech, Inc. (Columbia, US). The FDA issued a Cleared decision on October 31, 1996, 182 days after receiving the submission on May 2, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K961784 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 1996
Decision Date	October 31, 1996
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF