Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015347724

FEI Number

3015347724

Entity Name

Exel Inc. dba DHL Supply Chain (USA)

City/State/Country

Manchester, PA, US

Establishment Address

84 Zions View Road, Manchester, PA 17345, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Exel Inc. dba DHL Supply Chain (USA) (Owner Number: 10026656)

Owner / Operator Contact Address

360 Westar Blvd, Dept 555, Westerville, OH 43082, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110637

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-12-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-12-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-12-19
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-01-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-01-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-01-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-01-22
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-01-22
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2014-01-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-12-19
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-12-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-12-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-12-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-12-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-12-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-01-22
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-01-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-01-22
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-12-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-12-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-01-22
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-01-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-01-22
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-01-22
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2014-01-22
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-12-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-12-19

Official Correspondent

John Kropczynski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Exel Inc. dba DHL Supply Chain (USA)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015443199	Exel Inc.	Southaven, MS, US
3030821459	EXEL INC. DBA DHL SUPPLY CHAIN (USA)	York, PA, US
3010123014	Exel Inc. D/B/A DHL Supply Chain (USA)	Southaven, MS, US
3008868758	EXEL INC. DBA DHL SUPPLY CHAIN (USA)	Mooresville, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
K973662	Boehringer Mannheim Corp.	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	1997-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015347724. Last updated year: 2026. Please use registration number 3015347724 when referencing this establishment in official correspondence.