Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/Cmv Total Antibody Assays

FDA 510(k) K961784 · Sienna Biotech, Inc.

Substantially Equivalent

510(k) numberK961784

Submission

Device name
Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/Cmv Total Antibody Assays
Applicant
Sienna Biotech, Inc.
Columbia, MD, US
Received
May 2, 1996
Decision date
October 31, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LQN – Latex Agglutination Assay, Rubella
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3510
Specialty
Microbiology

Other 510(k)s with product code LQN

510(k)DeviceApplicantDecision
K031490RubellacolLQN · Traditional Immunostics Inc.,07/16/2003SE
K970931Copalis Torc Total Antibody AssayLQN · Traditional Sienna Biotech, Inc.04/24/1997SE
K954920Murex Rub-ExLQN · Traditional Murex Diagnostics, Inc.08/21/1996SE
K952544Colorslider RubellaLQN · Traditional Seradyn, Inc.01/17/1996SE
K912391Rubalex, ModificationLQN · Traditional Orion Corp.05/04/1992SE
K901637Resubmitted Modified RubalexLQN · Traditional Orion Corp.04/26/1990SE
K896433Modified RubagenLQN · Traditional Biokit USA, Inc.11/29/1989SE
K893755RubagenLQN · Traditional Biokit USA, Inc.08/21/1989SE
K861881Rubalex (Revised Version)LQN · Traditional Orion Corp.06/04/1986SE
K852788RubalexLQN · Traditional Orion Corp.03/12/1986SE

More from Orion Corp.

510(k)DeviceDecision
K970931Copalis Torc Total Antibody AssayLQN · Traditional 04/24/1997SE
K955799Copalis CMV Total Antibody AssayLJO · Traditional 07/10/1996SE

Questions and answers

When was Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/Cmv Total Antibody Assays cleared by the FDA?

Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/Cmv Total Antibody Assays (K961784) received a 510(k) decision of Substantially Equivalent on October 31, 1996, 182 days after the submission was received.

What is the product code of K961784?

The FDA product code is LQN – Latex Agglutination Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.