MRDx BCR-ABL Test, MRDx BCR-ABL Test Software— 510(k) K173492
UnknownMolecularmd Corporation
FDA 510(k) clearance K173492 for MRDx BCR-ABL Test, MRDx BCR-ABL Test Software, Unknown on 2017-12-22. Applicant: Molecularmd Corporation. Device class: 2.
Clearance details
- Applicant
- Molecularmd Corporation
- Product code
- Code OYX
- Device class
- Class 2
- Regulation
- 21 CFR 866.6060
- Advisory panel
- Medical Genetics
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Portland, OR, US
Recent devices under product code OYX
view all- K252243 — Fastplex BCR-ABL (p210) %IS digital PCR Kit
- K221869 — BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
- K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
- K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
- DEN160003 — Quantidex qPCR BCR-ABL IS Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.