510(k) K970718

Device: QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
Applicant: R & D SYSTEMS, INC.
510(k) number: K970718
Product code: JNM
Decision: Substantially Equivalent (SESE)
Decision date: 1997-05-27
Date received: 1997-02-26
Regulation: 866.5880
Classification name: Immunochemical, Transferrin
Medical specialty: Immunology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KENNETH T EDDS, PH.D.
Address: 614 Mckinley Pl. NE Minneapolis MN US 55413 55413

FDA Registration Numbers#

3004493545
3005360469
2432235

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00815762021657	Research and Diagnostic Systems	RESEARCH AND DIAGNOSTIC SYSTEMS, INC.	2016-07-29

Other 510(k) Records For Product Code JNM #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K992188	NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028	Nichols Institute Diagnostics	1999-12-06
K981208	TFR	Ramco Laboratories, Inc.	1998-10-21

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases