Data / Medical devices / United States / Diapharma Group, Inc.
Diapharma Group, Inc.: FDA-registered device maker in West Chester, OH, United States, 1 510(k) clearance
Diapharma Group, Inc. is registered with the FDA (registration 1530434) in West Chester, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1530434
- FEI number
- 3000719074
- Address
- 8948 Beckett Rd, West Chester, OH, United States, 45069
- Owner or operator
- DIAPHARMA GROUP, INC. (9029278)
- Roles
- Manufacturer
- First device listed
- October 9, 2007
- Registered through
- 2026
- Brand names listed
- DiaPharma Factor X
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plasma, Coagulation Factor Deficient | GJT | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 12, 2004 | K040362 | DIAPHARMA FACTOR X KIT | GJT | Substantially Equivalent | Diapharma Group, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 12, 2004. 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.