Data / Medical devices / United States / Cleveland Diagnostics, Inc.
Cleveland Diagnostics, Inc.: FDA-registered device maker in Cleveland, OH, United States, 1 PMA approval
Cleveland Diagnostics, Inc. is registered with the FDA (registration 3011015335) in Cleveland, OH, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated November 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011015335
- Address
- 3615 Superior Ave Ste 4406a, Cleveland, OH, United States, 44114
- Owner or operator
- Cleveland Diagnostics, Inc. (10095401)
- Roles
- Manufacturer, Repackager or relabeler, Reprocessor
- First device listed
- March 9, 2026
- Registered through
- 2026
- Brand names listed
- IsoPSA Assay
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer | QRF | 3 | Manufacturer, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 28, 2025 | P200048 | IsoPSA Assay | QRF | 1 | July 28, 2026 | accessdata.fda.gov |
Updated July 28, 2026. 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.