AbbVie NJ
510(k) K142792
AbbVie NJ is a Class II device made by Abbvie Inc., cleared under FDA 510(k) K142792 on 14 Jan 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK142792 | Date14 Jan 2015 | StatusActive |
Official records
- FDA 510(k) database K142792
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KNT
- FDA applicant
- AbbVie , Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESK Substantially Equivalent — Kit
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