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

Elan Holdings, Inc. · Predicate Candidate Screening

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

55 daysmedian FDA review time

94 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K013152	ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR K	Elan Holdings, Inc.	2001-11-09	50
K012474	ATAC PAK CPK REAGENT KIT	Elan Holdings, Inc.	2001-10-03	62
K010488	ATAC PAK AST REAGENT KIT	Elan Holdings, Inc.	2001-04-09	48
K000958	ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS	Elan Holdings, Inc.	2000-05-24	61
K000900	ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS	Elan Holdings, Inc.	2000-05-02	42
K992842	HICHEM ISE ELECTROLYTE REFERENCE	Elan Holdings, Inc.	1999-11-26	94
K992844	HICHEM ISE ELECTROLYTE BUFFER	Elan Holdings, Inc.	1999-11-26	94
K992845	HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CAL	Elan Holdings, Inc.	1999-10-18	55
K992846	HICHEM TOTAL PROTEIN REAGENT	Elan Holdings, Inc.	1999-10-18	55
K992847	HICHEM BUN REAGENT	Elan Holdings, Inc.	1999-10-14	51
K991789	ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIB	Elan Holdings, Inc.	1999-07-09	45
K991387	ELAN ALKALINE PHOSPHATE REAGENT KIT	Elan Holdings, Inc.	1999-05-19	28

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