Data / Medical devices / United States / American Brands LLC
American Brands LLC: FDA-registered device maker in Commerce Township, MI, United States, 2 510(k) clearances
American Brands LLC is registered with the FDA (registration 3017654330) in Commerce Township, MI, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017654330
- Address
- 3250 Old Farm Lane Suite 5, Commerce Township, MI, United States, 48390
- Owner or operator
- American Brands LLC (10079224)
- Roles
- Complaint file establishment
- First device listed
- January 5, 2024
- Registered through
- 2026
- Brand names listed
- Disposable Syringes LL Without Needle 10ml, 100 Syringe/Bx, Disposable Syringes LL Without Needle 1ml low dead space , 100 Syringe/Bx, Disposable Syringes LL Without Needle 20ml, 100 Syringe/Bx, Disposable Syringes LL Without Needle 3ml low dead space, 100 Syringe/Bx, Disposable Syringes LL Without Needle 5ml low dead space, 100 Syringe/Bx, Hypodermic Needle LL18gx1'', 100 Needle/Bx, Hypodermic Needle LL20gx1'', 100 Needle/Bx, Hypodermic Needle LL22gx1'', 100 Needle/Bx and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment | 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 6, 2020 | K191642 | TK Sterile Piston Syringe without Needle | FMF | Substantially Equivalent | Anhui Tiankang Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 19, 2019 | K191643 | TK Sterile Hypodermic Needle | FMI | Substantially Equivalent | Anhui Tiankang Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 6, 2020. 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.