TFR

FDA 510(k) K981208 · Ramco Laboratories, Inc.

Substantially Equivalent

510(k) numberK981208

Submission

Device name
TFR
Applicant
Ramco Laboratories, Inc.
Houston, TX, US
Received
April 2, 1998
Decision date
October 21, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JNM – Immunochemical, Transferrin
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5880
Specialty
Immunology

Other 510(k)s with product code JNM

510(k)DeviceApplicantDecision
K992188Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model…JNM · Traditional Nichols Institute Diagnostics12/06/1999SE
K970718Quantikine IVD STFR Enzyme Linked Immunosorbent Assay (Elisa)JNM · Traditional R&D Systems, Inc.05/27/1997SE

More from R&D Systems, Inc.

510(k)DeviceDecision
K983107VfeGGP · Traditional 10/22/1998SE
K910481Epo-RiaGGT · Traditional 11/29/1991SE
K872941Spectro CGGP · Traditional 09/04/1987SE
K864701VWF ImmunoblotGGP · Traditional 03/30/1987SE
K861159Spectro VWFGGP · Traditional 05/01/1986SE
K831470PTH MRCEW · Traditional 06/22/1983SE
K823016Candida Detection SystemLHK · Traditional 12/28/1982SE
K812056Spectro FeiritinDBF · Traditional 08/12/1981SE

Questions and answers

When was TFR cleared by the FDA?

TFR (K981208) received a 510(k) decision of Substantially Equivalent on October 21, 1998, 202 days after the submission was received.

What is the product code of K981208?

The FDA product code is JNM – Immunochemical, Transferrin, a Class II (moderate risk) device regulated under 21 CFR 866.5880.