Data / Medical devices / United States / Edlaw Pharmaceuticals, Inc.
Edlaw Pharmaceuticals, Inc.: FDA-registered device maker in E Farmingdale, NY, United States, 1 510(k) clearance
Edlaw Pharmaceuticals, Inc. is registered with the FDA (registration 2431908) in E Farmingdale, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 31, 1981. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2431908
- Address
- 195-B Central Ave., E Farmingdale, NY, United States, 11735
- Owner or operator
- EDLAW PHARMACEUTICALS, INC. (2431908)
- Roles
- Repackager or relabeler
- First device listed
- February 16, 2016
- Registered through
- 2027
- Brand names listed
- Hemo-Dial
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 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 |
|---|---|---|---|---|---|---|
| December 31, 1981 | K813388 | HEMODIALYSATE | KPO | Substantially Equivalent | Edlaw Pharmaceuticals, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 31, 1981. 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.