Autozyme Screen

FDA 510(k) K940700 · Cambridge Life Sciences Plc.

Substantially Equivalent

510(k) numberK940700

Submission

Device name
Autozyme Screen
Applicant
Cambridge Life Sciences Plc.
Ely, Cambridgeshire, GB
Received
February 16, 1994
Decision date
June 10, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

Other 510(k)s with product code LJM

510(k)DeviceApplicantDecision
K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional Phadia AB11/27/2018SE
K151559ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional Immco Diagnostics, Inc.03/11/2016SE
K140493Elia SCL-70S ImmunoassayLJM · Traditional Phadia GmbH10/30/2014SE
K123880Quanta Flash CentromereLJM · Traditional Inova Diagnostics, Inc.02/07/2014SE
K131330Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional Gold Standard Diagnostics01/28/2014SE
K131185Ana Screen Elisa (Igg)LJM · Traditional Euroimmun US07/15/2013SE
K083188Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional Phadia US, Inc.03/13/2009SE
K050967Varelisa Recombi CTD Screen, Model 13096LJM · Traditional Sweden Diagnostics (Germany) GmbH06/28/2005SE
K050625Varelisa Recombi Ana Profile, Model 18496LJM · Traditional Sweden Diagnostics (Germany) GmbH04/26/2005SE
K041102Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional Immco Diagnostics, Inc.10/26/2004SE

More from Immco Diagnostics, Inc.

510(k)DeviceDecision
K940585Selisa Anti-N DNA AntibodiesLRM · Traditional 06/10/1994SE
K922241AutozymeLLL · Traditional 11/30/1992SE
K891869CLS 962 Microplate PhotometerJJQ · Traditional 05/09/1989SE

Questions and answers

When was Autozyme Screen cleared by the FDA?

Autozyme Screen (K940700) received a 510(k) decision of Substantially Equivalent on June 10, 1994, 114 days after the submission was received.

What is the product code of K940700?

The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.