FDA 510(k) Applications for Medical Device Product Code "DGO"
(Ige, Peroxidase, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K893125 BECKMAN INSTRUMENTS, INC. BECKMAN EPSILON(TM) IGE REAGENT KIT 06/16/1989
K831987 BECKMAN INSTRUMENTS, INC. EPSILON IGE TEST KIT 10/14/1983
K800995 CALBIOCHEM-BEHRING CORP. IMMUNOGLOBULIN E TEST KIT 05/14/1980
K853607 DEXALL BIOMEDICAL LABS, INC. ALLERG-E IGE ENZYME IMMUNOASSAY KIT 11/07/1985
K911511 DIAGNOSTIC PRODUCTS CORP. ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED 04/17/1991
K872801 DIAGNOSTIC PRODUCTS CORP. ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 09/10/1987
K943194 DIAGNOSTIC PRODUCTS CORP. IMMULITE(R) ALLERGY FOOD PANEL FP5E 02/23/1995
K821094 DIAGNOSTIC REAGENT TECH. IP SPECIFIC E 05/07/1982
K831774 DIAGNOSTIC REAGENT TECH. LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- 07/18/1983
K831984 DIAGNOSTIC REAGENT TECH. POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE 11/21/1983
K830495 DIAGNOSTIC REAGENT TECH. POLYSTYRENE MICROTITER PLATE IMMUNOSOR 04/05/1983
K830653 DIAGNOSTIC REAGENT TECH. POLYSTYRENE MICROTITER PLATE IMMUNOSORB 04/08/1983
K860851 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM 03/28/1986
K894039 QUIDEL CORP. QUIDEL TOTAL IGE TEST "QUANTITATIVE VERSION" 07/14/1989
K920087 THE BINDING SITE, LTD. IGE EIA TEST KIT 09/14/1992


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact