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ELITechGroup Inc: FDA-registered device maker in Logan, UT, United States, 7 510(k) clearances

Name: ELITechGroup Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ELITechGroup Inc is registered with the FDA (registration 1717966) in Logan, UT, United States. It lists 26 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 27, 2018. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1717966
Address: 370 West 1700 South, Logan, UT, United States, 84321
Owner or operator: ELITechGroup Inc. (1717966)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 27, 2001
Registered through: 2026
Brand names listed: AFB/TB Stain Control Slides, Accu-Sed® Plus Abnormal ESR Control, 5x8.5mL, Accu-Sed® Plus Normal / Abnormal ESR Control Set, 10x8.5mL, Accu-Sed® Plus Normal / Abnormal ESR Control, 2x8.5mL, Accu-Sed® Plus Normal / Abnormal ESR Control, 4x8.5 mL, Accu-Sed® Plus Normal ESR Control, 5x8.5mL, Acid Solution, Aerofix® for Aerospray® Gram and TB Stainers and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Contract manufacturer	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Contract manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality	JMZ	1	Manufacturer	accessdata.fda.gov
Coulometric, Chloride	JFS	2	Manufacturer, Specification developer	accessdata.fda.gov
Cytocentrifuge	IFB	1	Manufacturer	accessdata.fda.gov
Device, Automated Sedimentation Rate	GKB	1	Manufacturer, Specification developer	accessdata.fda.gov
Device, Iontophoresis, Specific Uses	KTB	2	Manufacturer	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Selective (Non-Specified)	JJP	1	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Contract manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Contract manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Contract manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Contract manufacturer	accessdata.fda.gov
Osmometer For Clinical Use	JJM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Quality Control Slides	LJG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Slide Stainer, Automated	KPA	1	Manufacturer	accessdata.fda.gov
Stains, Microbiologic	JTS	1	Manufacturer	accessdata.fda.gov
Vapor Pressure, Osmolality Of Serum & Urine	JNA	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 27, 2018	K180627	Macroduct Advanced Model 3710	KTB	Substantially Equivalent	Elitechgroup, Inc.	accessdata.fda.gov
March 27, 2013	K121823	CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC	JFS	Substantially Equivalent	Wescor, Inc.	accessdata.fda.gov
October 21, 2003	K032608	GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER	JIS	Substantially Equivalent	Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB	accessdata.fda.gov
August 6, 2003	K031539	HEMOGLOBIN A1C REAGENT SET	LCP	Substantially Equivalent	Pointe Scientific, Inc.,	accessdata.fda.gov
March 20, 2001	K010031	NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM	KTB	Substantially Equivalent	Wescor, Inc.	accessdata.fda.gov
May 24, 1988	K863395	WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER	CGZ	Substantially Equivalent	Wescor, Inc.	accessdata.fda.gov
October 16, 1985	K853973	WESCOR MODEL 3700 WEBSTER SWEAT INDUCER	KTB	Substantially Equivalent	Wescor, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 29, 2013	66202	Class II	Terminated	Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum	High positive calcium bias on plasma sample versus results on serum	accessdata.fda.gov
April 12, 2010	55535	Not yet classified	Terminated	Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. Slider allows a larger label to be applied to the	The tube may fall out or separate from the Slider adapter	accessdata.fda.gov
January 6, 2010	54187	Not yet classified	Terminated	SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. Specifically for use on the Wescor 7120 Hematology Aerospray Slide Stainer and is intended for use by medical professionals to stain	Stains used for diagnostic use may be contaminated with bacteria.	accessdata.fda.gov
December 4, 2009	54279	Not yet classified	Terminated	Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.	Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.	accessdata.fda.gov
December 26, 2007	46214	Not yet classified	Terminated	Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.	Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.	accessdata.fda.gov

Compare with other makers

Updated July 27, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.