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DGO — Ige, Peroxidase, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DGO
Device Class
Class II
Regulation Number
866.5510
Submission Type
Review Panel
PA
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K943194diagnostic productsIMMULITE(R) ALLERGY FOOD PANEL FP5EFebruary 23, 1995
K920087binding siteIGE EIA TEST KITSeptember 14, 1992
K911511diagnostic productsALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIEDApril 17, 1991
K894039quidelQUIDEL TOTAL IGE TEST QUANTITATIVE VERSIONJuly 14, 1989
K893125beckman instrumentsBECKMAN EPSILON(TM) IGE REAGENT KITJune 16, 1989
K872801diagnostic productsALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5September 10, 1987
K860851nichols institute diagnosticsALLEGRO IGE ENZYME IMMUNOASSAY SYSTEMMarch 28, 1986
K853607dexall biomedical labsALLERG-E IGE ENZYME IMMUNOASSAY KITNovember 7, 1985
K831984diagnostic reagent techPOLYSTYRENE MICRO-LITER PLATE-BIRCHTREENovember 21, 1983
K831987beckman instrumentsEPSILON IGE TEST KITOctober 14, 1983
K831774diagnostic reagent techLOGIPE A DATA REDUCSYSTEM IP SPECIFIC-July 18, 1983
K830653diagnostic reagent techPOLYSTYRENE MICROTITER PLATE IMMUNOSORBApril 8, 1983
K830495diagnostic reagent techPOLYSTYRENE MICROTITER PLATE IMMUNOSORApril 5, 1983
K821094diagnostic reagent techIP SPECIFIC EMay 7, 1982
K800995calbiochem-behringIMMUNOGLOBULIN E TEST KITMay 14, 1980