Atlas FDA

DGO

15 FDA 510(k) clearances · Product code

48 daysmedian time to decision
233 days90th percentile
15clearances measured

FDA profile

Official device name
Ige, Peroxidase, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
IMMULITE(R) ALLERGY FOOD PANEL FP5E (K943194)Diagnostic Products Corp.1995-02-23
IGE EIA TEST KIT (K920087)The Binding Site, Ltd.1992-09-14
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED (K911511)Diagnostic Products Corp.1991-04-17
QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION (K894039)Quidel Corp.1989-07-14
BECKMAN EPSILON(TM) IGE REAGENT KIT (K893125)Beckman Instruments, Inc.1989-06-16
ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 (K872801)Diagnostic Products Corp.1987-09-10
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM (K860851)Nichols Institute Diagnostics1986-03-28
ALLERG-E IGE ENZYME IMMUNOASSAY KIT (K853607)Dexall Biomedical Labs, Inc.1985-11-07
POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (K831984)Diagnostic Reagent Tech.1983-11-21
EPSILON IGE TEST KIT (K831987)Beckman Instruments, Inc.1983-10-14
LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- (K831774)Diagnostic Reagent Tech.1983-07-18
POLYSTYRENE MICROTITER PLATE IMMUNOSORB (K830653)Diagnostic Reagent Tech.1983-04-08
POLYSTYRENE MICROTITER PLATE IMMUNOSOR (K830495)Diagnostic Reagent Tech.1983-04-05
IP SPECIFIC E (K821094)Diagnostic Reagent Tech.1982-05-07
IMMUNOGLOBULIN E TEST KIT (K800995)Calbiochem-Behring Corp.1980-05-14

Track DGO automatically

Every clearance here is in the API, with alerts when new ones post.