Immustrip(Tm) SM Elisa Test System

FDA 510(k) K873741 · Immunomedics, Inc.

Substantially Equivalent

510(k) numberK873741

Submission

Device name
Immustrip(Tm) SM Elisa Test System
Applicant
Immunomedics, Inc.
Newark, NJ, US
Received
September 16, 1987
Decision date
November 4, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LKP – Anti-Sm Antibody, Antigen And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

Other 510(k)s with product code LKP

510(k)DeviceApplicantDecision
K202067EliA SmDP-SLKP · Traditional Phadia AB07/14/2021SE
K183007EliA SmDP ImmunoassayLKP · Traditional Phadia AB12/24/2018SE
K132631Eia SMDP ImmunoassayLKP · Traditional Phadia US, Inc.08/29/2014SE
K123593Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP…LKP · Traditional Inova Diagnostics, Inc.04/17/2013SE
K051066Theratest El-Ana ProfilesLKP · Traditional Theratest Laboratories, Inc.10/07/2005SE
K042629Varelisa SM Antibodies, Model 18296LKP · Traditional Sweden Diagnostics (Germany) GmbH12/08/2004SE
K024219Liquichek Anti-Sm Control, Positive, Catalog #115LKP · Traditional Bio-Rad01/15/2003SE
K013263Fred Hutchinson Cancer Research Center Enzyme Anti-Sr Protein Antibody TestLKP · Traditional Fred Hutchinson Cancer Research Center07/29/2002SE
K000755Rhigene MESACUP2 Test- SMLKP · Traditional Rhigene, Inc.05/09/2000SE
K000312Varelisa SM AntibodiesLKP · Traditional Pharmacia & Upjohn Co.03/17/2000SE

More from Pharmacia & Upjohn Co.

510(k)DeviceDecision
K972873Immustrip Hama IggDAK · Traditional 03/17/1998SE
K870903Immustrip(Tm) Dsdna Elisa Test SystemLRM · Traditional 05/14/1987SE
K861362Immunomedics Serum Elisa Test SystemCZW · Traditional 06/06/1986SE

Questions and answers

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

Immustrip(Tm) SM Elisa Test System (K873741) received a 510(k) decision of Substantially Equivalent on November 4, 1987, 49 days after the submission was received.

What is the product code of K873741?

The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.