Cleared Traditional

COPALIS TORC TOTAL ANTIBODY ASSAY

K970931 · Sienna Biotech, Inc. · Microbiology

Apr 1997

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K970931 is an FDA 510(k) clearance for the COPALIS TORC TOTAL ANTIBODY ASSAY, 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 April 24, 1997, 48 days after receiving the submission on March 7, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K970931 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 1997
Decision Date	April 24, 1997
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF