Human Igg Subclasses Rid Combi Kit (Modification)

FDA 510(k) K943205 · Research Diagnostics, Inc.

Substantially Equivalent

510(k) numberK943205

Submission

Device name
Human Igg Subclasses Rid Combi Kit (Modification)
Applicant
Research Diagnostics, Inc.
Flanders, NJ, US
Received
July 5, 1994
Decision date
September 7, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DAS – Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Device class
Class I (low risk)
Regulation
21 CFR 866.5530
Specialty
Immunology

Other 510(k)s with product code DAS

510(k)DeviceApplicantDecision
K982023Pelicalss Human Igg Subclass Nephlometric Array KitDAS · Traditional Inova Diagnostics, Inc.09/04/1998SE
K944876Human Igg Subclasses Nephelometric Bna KitDAS · Traditional Research Diagnostics, Inc.12/15/1994SE
K943098Human Igg Subclasses Elisa Combi KitDAS · Traditional Research Diagnostics, Inc.09/07/1994SE
K895600Human (Igg) Subclass (Eia) KitDAS · Traditional The Binding Site, Ltd.11/08/1989SE
K790708Antiserum to Human Ig G FC FragmentsDAS · Traditional Kent Laboratories, Inc.08/22/1979SE
K790715Antiserum to Human FCDAS · Traditional Kent Laboratories, Inc.08/16/1979SE
K761156Aminoglycoside ControlsDAS · Traditional Supelco, Inc.12/09/1976SE

More from Supelco, Inc.

510(k)DeviceDecision
K944876Human Igg Subclasses Nephelometric Bna KitDAS · Traditional 12/15/1994SE
K943098Human Igg Subclasses Elisa Combi KitDAS · Traditional 09/07/1994SE

Questions and answers

When was Human Igg Subclasses Rid Combi Kit (Modification) cleared by the FDA?

Human Igg Subclasses Rid Combi Kit (Modification) (K943205) received a 510(k) decision of Substantially Equivalent on September 7, 1994, 64 days after the submission was received.

What is the product code of K943205?

The FDA product code is DAS – Igg (Fc Fragment Specific), Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5530.