Data / Medical devices / United States / Exel Inc. dba DHL Supply Chain (USA)
Exel Inc. dba DHL Supply Chain (USA): FDA-registered device maker in Manchester, PA, United States, 15 510(k) clearances
Exel Inc. dba DHL Supply Chain (USA) is registered with the FDA (registration 3015347724) in Manchester, PA, United States. It lists 6 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 26, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015347724
- Address
- 84 Zions View Road, Manchester, PA, United States, 17345
- Owner or operator
- Exel Inc. dba DHL Supply Chain (USA) (10026656)
- Roles
- Repackager or relabeler
- First device listed
- December 19, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Repackager or relabeler | 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 26, 2012 | K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | LFR | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| March 28, 2012 | K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) | LFR | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| September 7, 2011 | K110637 | ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM | LFR | Substantially Equivalent | Cilag GmbH International | accessdata.fda.gov |
| February 11, 2011 | K093745 | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| February 10, 2011 | K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION | JJX | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| August 26, 2009 | K091820 | CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM | NBW | Substantially Equivalent | Bayer Healthcare | accessdata.fda.gov |
| April 18, 2008 | K073231 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| October 5, 2007 | K072543 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| November 22, 2006 | K062347 | ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| September 11, 2006 | K062058 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 | NBW | Substantially Equivalent | Bayer Healthcare | accessdata.fda.gov |
| August 16, 2006 | K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| May 19, 2006 | K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| January 17, 2006 | K053529 | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| October 24, 2002 | K023194 | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM | CGA | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| August 23, 2002 | K021819 | ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Calculator/Data Processing Module, For Clinical Use
Updated July 26, 2012. 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.