Allergenetics Aller-Specific Ige Serum

FDA 510(k) K842969 · Allergenetics

Substantially Equivalent

510(k) numberK842969

Submission

Device name
Allergenetics Aller-Specific Ige Serum
Applicant
Allergenetics
Mchenry, IL, US
Received
July 30, 1984
Decision date
August 28, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DGP – Ige, Fitc, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

Other 510(k)s with product code DGP

510(k)DeviceApplicantDecision
K931224Vidas Total Ige (Ige) AssayDGP · Traditional Biomerieux Vitek, Inc.05/20/1993SE
K863327Immpulse Ige Assay ReagentsDGP · Traditional Sclavo, Inc.12/03/1986SE
K842749Fiax Total Ige Test KitDGP · Traditional Intl. Diagnostic Technology08/28/1984SE

More from Intl. Diagnostic Technology

510(k)DeviceDecision
K851512Allergenetics Ige Fast TestDHB · Traditional 05/28/1985SE
K842970Allergentics Total Ige/TheophyllineJJY · Traditional 08/29/1984SE
K833418Chymofast TestDHB · Traditional 03/12/1984SE
K834594Total Ige Fast TestDGC · Traditional 02/10/1984SE
K833419Labeled 125I Anti-IgeDGC · Traditional 02/03/1984SE
K834244Theofast Test Kit for Quantitative TheoKLS · Traditional 01/24/1984SE
K822341Allergenetics Ige-Fast TestDGC · Traditional 11/10/1982SE

Questions and answers

When was Allergenetics Aller-Specific Ige Serum cleared by the FDA?

Allergenetics Aller-Specific Ige Serum (K842969) received a 510(k) decision of Substantially Equivalent on August 28, 1984, 29 days after the submission was received.

What is the product code of K842969?

The FDA product code is DGP – Ige, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.