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

Elitechgroup — Predicate Candidate Screening

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

64 daysmedian FDA review time

242 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K180559	HSV 1 & 2 ELITe MGB Kit; ELITe InGenius	Elitechgroup	2018-10-29	242	0
K171401	ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinic	Elitechgroup	2017-07-11	60	0
K153644	ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Sys	Elitechgroup	2016-09-07	261	0
K151113	ELITech Clinical Systems CALCIUM ARSENAZO	Elitechgroup	2015-07-22	86	0
K151552	ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems	Elitechgroup	2015-07-08	29	0
K141265	ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT	Elitechgroup	2014-07-18	64	0
K132399	ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITRO	Elitechgroup	2014-01-03	155	0
K130765	ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS	Elitechgroup	2013-04-04	15	0
K122177	ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 1	Elitechgroup	2013-02-15	207	0
K122858	ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS E	Elitechgroup	2012-10-03	15	0
K122083	ELITECH CLINICAL SYSTEMS CK NAC SL	Elitechgroup	2012-08-22	37	0
K113269	ELITTECH CLINICAL SYSTEMS ALP IFCC SL	Elitechgroup	2011-12-29	55	0
K111960	ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH C	Elitechgroup	2011-11-18	130	0
K110780	ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINIC	Elitechgroup	2011-10-07	200	0
K111996	ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2	Elitechgroup	2011-09-14	63	0
K112029	ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS	Elitechgroup	2011-08-30	46	0
K110830	ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL	Elitechgroup	2011-06-21	88	1

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