The following data is part of a premarket notification filed by Qiagen, Gmbh with the FDA for Rotor-gene Q Mdx.
| Device ID | K113319 |
| 510k Number | K113319 |
| Device Name: | ROTOR-GENE Q MDX |
| Classification | Real Time Nucleic Acid Amplification System |
| Applicant | QIAGEN, GMBH 1201 CLOPPER RD Gaithersburg, MD 20878 |
| Contact | Melissa Mahall |
| Correspondent | Melissa Mahall QIAGEN, GMBH 1201 CLOPPER RD Gaithersburg, MD 20878 |
| Product Code | OOI |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-10 |
| Decision Date | 2012-02-06 |
| Summary: | summary |