510(k) K981208

Device: TFR
Applicant: RAMCO LABORATORIES, INC.
510(k) number: K981208
Product code: JNM
Decision: Substantially Equivalent (SESE)
Decision date: 1998-10-21
Date received: 1998-04-02
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: JEFFREY B GRUBB
Address: 4507 Mt.Vernon Houston TX US 77006 77006

FDA Registration Numbers#

3004493545
3005360469
2432235

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08600000686031	TfR	Ramco Laboratories, Inc.	2019-03-26

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
K970718	QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)	R&D Systems, Inc.	1997-05-27

Legacy Summary#

summary

FDA Review#

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