Immustrip(Tm) Dsdna Elisa Test System

Q: What is the product code of K870903?

The FDA product code is LRM – Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.

FDA 510(k) K870903 · Immunomedics, Inc.

Substantially Equivalent

510(k) numberK870903

Submission

Device name: Immustrip(Tm) Dsdna Elisa Test System
Applicant: Immunomedics, Inc.
Newark, NJ, US
Received: March 5, 1987
Decision date: May 14, 1987
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LRM – Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5100
Specialty: Immunology

Other 510(k)s with product code LRM

510(k)	Device	Applicant	Decision
K101319	Immulisa Dsdna Antibody ElisaLRM · Traditional	Immco Diagnostics, Inc.	12/09/2010SE
K083381	Euroimmun Anti-Dsdna-Ncx Elisa (Igg)LRM · Traditional	Euroimmun Us, Inc.	04/15/2009SE
K062183	Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay KitLRM · Traditional	The Binding Site, Ltd.	11/21/2006SE
K040811	Varelisa Ssdna Antibodies, Model 14896LRM · Traditional	Pharmacia Deutschland GmbH	05/13/2004SE
K001900	Enzyme Immunoassay Anti-Ssdna Antibody TestLRM · Traditional	Helix Diagnostics, Inc.	09/11/2000SE
K000477	Mdi Ds-Dna TestLRM · Traditional	Micro Detect, Inc.	03/01/2000SE
K994424	Diamedix Is-Anti-Dsdna Test SystemLRM · Traditional	Diamedix Corp.	02/18/2000SE
K993727	Bindazyme Anti-Dsdna Eia KitLRM · Traditional	The Binding Site, Ltd.	12/21/1999SE
K984396	Liquichek Anti-Dsdna Control, Model 213LRM · Traditional	Bio-Rad	12/18/1998SE
K983422	The Aptus (Automated) Applications of the DS DNA Elisa Test System Linked Immunosorbent…LRM · Traditional	Zeus Scientific, Inc.	11/18/1998SE

More from Zeus Scientific, Inc.

510(k)	Device	Decision
K972873	Immustrip Hama IggDAK · Traditional	03/17/1998SE
K873741	Immustrip(Tm) SM Elisa Test SystemLKP · Traditional	11/04/1987SE
K861362	Immunomedics Serum Elisa Test SystemCZW · Traditional	06/06/1986SE

Questions and answers

When was Immustrip(Tm) Dsdna Elisa Test System cleared by the FDA?

Immustrip(Tm) Dsdna Elisa Test System (K870903) received a 510(k) decision of Substantially Equivalent on May 14, 1987, 70 days after the submission was received.

What is the product code of K870903?

The FDA product code is LRM – Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.