510(k) K113319 ยท OOI Real Time Nucleic Acid Amplification System
ROTOR-GENE Q MDX
| Applicant | QIAGEN GmbH, Gaithersburg MD, US |
| Decision | Substantially Equivalent, Feb 6, 2012 |
| Received | Nov 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113319
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2020 | Qiagen Sciences LLC QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays. Terminated |
OOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.