Radial Immunodiffusion Kit-Complement

FDA 510(k) K772075 · Gelman Instrument Co.

Substantially Equivalent

510(k) numberK772075

Submission

Device name
Radial Immunodiffusion Kit-Complement
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
DAY – Complement C5, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5240
Specialty
Immunology

Other 510(k)s with product code DAY

510(k)DeviceApplicantDecision
K942326Human C5 Rid KitsDAY · Traditional Jay H. Geller08/24/1995SE
K950102Human C-5 Radial Immunodiffusion KitDAY · Traditional Kent Laboratories, Inc.04/10/1995SE

More from Kent Laboratories, Inc.

510(k)DeviceDecision
K772080Radial Immunodiffusion Kit-Alph-L-AntitDEM · Traditional 02/03/1978SE
K772079Radial Immunodiffusion Kit-Immunoglob.MDFL · 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
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-Complement cleared by the FDA?

Radial Immunodiffusion Kit-Complement (K772075) 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 K772075?

The FDA product code is DAY – Complement C5, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.