Data / Medical devices / United States / Molecularmd Corporation
Molecularmd Corporation: FDA-registered device maker in Portland, OR, United States, 1 510(k) clearance
Molecularmd Corporation is registered with the FDA (registration 3007125666) in Portland, OR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007125666
- Address
- 1341 SW Custer Drive, Portland, OR, United States, 97219
- Owner or operator
- MolecularMD Corporation, an ICON plc company (10056701)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 8, 2018
- Registered through
- 2026
- Brand names listed
- MRDx BCR-ABL Test, MRDx BCR-ABL Test Software, MRDx Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bcr/Abl1 Monitoring Test | OYX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 22, 2017 | K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | OYX | Unknown | Molecularmd Corporation | accessdata.fda.gov |
Compare with other makers
Updated December 22, 2017. 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.