Data / Medical devices / United States / Almac Pharma Services LLC
Almac Pharma Services LLC: FDA-registered device maker in Audubon, PA, United States, 1 510(k) clearance
Almac Pharma Services LLC is registered with the FDA (registration 3000214934) in Audubon, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 15, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000214934
- Address
- 2661 Audubon RD, Audubon, PA, United States, 19403
- Owner or operator
- Almac Pharma Services Limited (10055056)
- Roles
- Repackager or relabeler
- First device listed
- June 5, 2017
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 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 |
|---|---|---|---|---|---|---|
| April 15, 2010 | K100005 | BD PEN NEEDLE | FMI | Substantially Equivalent | Becton, Dickinson and Co. | accessdata.fda.gov |
Compare with other makers
Updated April 15, 2010. 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.