Varelisa Histone Antibodies, Model 16496

Q: What is the product code of K040810?

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

FDA 510(k) K040810 · Pharmacia Deutschland GmbH

Substantially Equivalent

510(k) numberK040810

Submission

Device name: Varelisa Histone Antibodies, Model 16496
Applicant: Pharmacia Deutschland GmbH
Freiburg, DE
Received: March 29, 2004
Decision date: May 14, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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)	Device	Applicant	Decision
K182353	EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional	Phadia AB	11/27/2018SE
K151559	ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional	Immco Diagnostics, Inc.	03/11/2016SE
K140493	Elia SCL-70S ImmunoassayLJM · Traditional	Phadia GmbH	10/30/2014SE
K123880	Quanta Flash CentromereLJM · Traditional	Inova Diagnostics, Inc.	02/07/2014SE
K131330	Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional	Gold Standard Diagnostics	01/28/2014SE
K131185	Ana Screen Elisa (Igg)LJM · Traditional	Euroimmun US	07/15/2013SE
K083188	Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional	Phadia US, Inc.	03/13/2009SE
K050967	Varelisa Recombi CTD Screen, Model 13096LJM · Traditional	Sweden Diagnostics (Germany) GmbH	06/28/2005SE
K050625	Varelisa Recombi Ana Profile, Model 18496LJM · Traditional	Sweden Diagnostics (Germany) GmbH	04/26/2005SE
K041102	Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional	Immco Diagnostics, Inc.	10/26/2004SE

More from Immco Diagnostics, Inc.

510(k)	Device	Decision
K041043	Varelisa PR3 Anca, Model Number 17748/17796MOB · Traditional	07/02/2004SE
K040811	Varelisa Ssdna Antibodies, Model 14896LRM · Traditional	05/13/2004SE
K040452	Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096MSV · Traditional	05/11/2004SE
K040451	Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896MSV · Traditional	05/11/2004SE
K040450	Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996MSV · Traditional	05/11/2004SE
K040449	Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796MSV · Traditional	05/11/2004SE
K020758	Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696MID · Traditional	05/02/2002SE
K020757	Varelisa Cardiolipin Iga Antibodies, Models 15748 & 15796MID · Traditional	05/02/2002SE
K020752	Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596MID · Traditional	05/02/2002SE

Questions and answers

When was Varelisa Histone Antibodies, Model 16496 cleared by the FDA?

Varelisa Histone Antibodies, Model 16496 (K040810) received a 510(k) decision of Substantially Equivalent on May 14, 2004, 46 days after the submission was received.

What is the product code of K040810?

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