Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DGO — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

48 daysmedian FDA review time

233 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K943194	IMMULITE(R) ALLERGY FOOD PANEL FP5E	Diagnostic Products Corp.	1995-02-23	233
K920087	IGE EIA TEST KIT	The Binding Site, Ltd.	1992-09-14	250
K911511	ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED	Diagnostic Products Corp.	1991-04-17	13
K894039	QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION	Quidel Corp.	1989-07-14	38
K893125	BECKMAN EPSILON(TM) IGE REAGENT KIT	Beckman Instruments, Inc.	1989-06-16	52
K872801	ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5	Diagnostic Products Corp.	1987-09-10	57
K860851	ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM	Nichols Institute Diagnostics	1986-03-28	21
K853607	ALLERG-E IGE ENZYME IMMUNOASSAY KIT	Dexall Biomedical Labs, Inc.	1985-11-07	71
K831984	POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE	Diagnostic Reagent Tech.	1983-11-21	154
K831987	EPSILON IGE TEST KIT	Beckman Instruments, Inc.	1983-10-14	115
K831774	LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-	Diagnostic Reagent Tech.	1983-07-18	46
K830653	POLYSTYRENE MICROTITER PLATE IMMUNOSORB	Diagnostic Reagent Tech.	1983-04-08	38
K830495	POLYSTYRENE MICROTITER PLATE IMMUNOSOR	Diagnostic Reagent Tech.	1983-04-05	48
K821094	IP SPECIFIC E	Diagnostic Reagent Tech.	1982-05-07	18
K800995	IMMUNOGLOBULIN E TEST KIT	Calbiochem-Behring Corp.	1980-05-14	19

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda