The following data is part of a premarket notification filed by Molecularmd Corporation with the FDA for Mrdx Bcr-abl Test, Mrdx Bcr-abl Test Software.
| Device ID | K173492 |
| 510k Number | K173492 |
| Device Name: | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software |
| Classification | Bcr/abl1 Monitoring Test |
| Applicant | MolecularMD Corporation 1341 SW Custer Drive Portland, OR 97219 |
| Contact | Kevin Hawkins |
| Correspondent | Kevin Hawkins MolecularMD Corporation 1341 SW Custer Drive Portland, OR 97219 |
| Product Code | OYX |
| CFR Regulation Number | 866.6060 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2017-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B60290100280 | K173492 | 000 |