Data / Medical devices / United States / AbbVie Inc
AbbVie Inc: FDA-registered device maker in North Chicago, IL, United States, 3 510(k) clearances
AbbVie Inc is registered with the FDA (registration 3010757606) in North Chicago, IL, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 14, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010757606
- Address
- 1 N Waukegan Rd, North Chicago, IL, United States, 60064
- Owner or operator
- AbbVie Inc. (10046068)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 21, 2015
- Registered through
- 2026
- Brand names listed
- AbbVie Belt Pouch for Vyafuser, AbbVie Chest Pack, AbbVie Combined Fitted Vest, AbbVie Cross Body Pack, AbbVie Fitted Belt, AbbVie Fitted Vest, AbbVie Hip Pack, AbbVie J and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 14, 2015 | K142816 | AbbVie J | KNT | Substantially Equivalent | AbbVie , Inc. | accessdata.fda.gov |
| January 14, 2015 | K142793 | AbbVie PEG | KNT | Unknown | AbbVie , Inc. | accessdata.fda.gov |
| January 14, 2015 | K142792 | AbbVie NJ | KNT | Unknown | AbbVie , Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 14, 2015. 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.