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

Elan Diagnostics — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

67 daysmedian FDA review time

267 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K030003	ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR	Elan Diagnostics	2003-09-29	270
K030014	ATAC TOTAL BILIRUBIN REAGENT	Elan Diagnostics	2003-09-26	267
K030621	ATAC CALIBRATOR	Elan Diagnostics	2003-03-19	20
K023105	ATAC CALCIUM REAGENT AND ATAC CALIBRATOR	Elan Diagnostics	2003-03-13	176
K030010	ATAC PAK MAGNESIUM REAGENT	Elan Diagnostics	2003-03-10	67
K030015	ATAC PAK PHOSPHORUS REAGENT	Elan Diagnostics	2003-03-07	64
K030006	ATAC PAK ALBUMIN REAGENT	Elan Diagnostics	2003-03-07	64
K023407	ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR	Elan Diagnostics	2003-02-14	127
K021385	ATAC PAK BUN REAGENT	Elan Diagnostics	2002-07-12	71
K020575	ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS	Elan Diagnostics	2002-04-12	50
K002285	ATAC PAK ALP REAGENT KIT	Elan Diagnostics	2000-09-26	62
K000556	ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS	Elan Diagnostics	2000-05-17	89
K992029	ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATO	Elan Diagnostics	1999-08-12	57

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