Radial Immunodiffusion Kit-Immunoglob.M

FDA 510(k) K772079 · Gelman Instrument Co.

Substantially Equivalent

510(k) numberK772079

Submission

Device name
Radial Immunodiffusion Kit-Immunoglob.M
Applicant
Gelman Instrument Co.
Mchenry, IL, US
Received
November 3, 1977
Decision date
February 3, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DFL – Igm, Ferritin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5550
Specialty
Immunology

Other 510(k)s with product code DFL

510(k)DeviceApplicantDecision
K883493Technicon DPA-1 Immunoglobulin MDFL · Traditional Technicon Instruments Corp.09/22/1988SE
K882822Fiagen FerritinDFL · Traditional Cyberfluor, Inc.08/04/1988SE

More from Cyberfluor, Inc.

510(k)DeviceDecision
K772080Radial Immunodiffusion Kit-Alph-L-AntitDEM · Traditional 02/03/1978SE
K772078Radial Immunodiffusion Kit-HaptoglobinDAB · Traditional 02/03/1978SE
K772077Radial Immunodiffusion Kit-Immunoglob.GDEW · Traditional 02/03/1978SE
K772076Radial Immunodiffusion Kit-Immunoglob.CZP · Traditional 02/03/1978SE
K772075Radial Immunodiffusion Kit-ComplementDAY · Traditional 02/03/1978SE
K772074Radial Immunodiffusion Kit-TransferrinDDI · Traditional 02/03/1978SE
K772073Radial Immunodiffusion Kit-Comp. 3DBI · Traditional 02/03/1978SE
K772325Densitometer 18, Computing, Auto.JQT · Traditional 01/12/1978SE
K771812Lippoprotein Electrophoresis Reagent SetDFC · Traditional 10/18/1977SE
K770155Alkaline Phosphatase Isoyzme Reagent SetCJO · Traditional 01/31/1977SE

Questions and answers

When was Radial Immunodiffusion Kit-Immunoglob.M cleared by the FDA?

Radial Immunodiffusion Kit-Immunoglob.M (K772079) received a 510(k) decision of Substantially Equivalent on February 3, 1978, 92 days after the submission was received.

What is the product code of K772079?

The FDA product code is DFL – Igm, Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.