510(k) K143653 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Sep 4, 2015 |
| Received | Dec 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2022 | Luminex Corporation Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system Open, Classified |
OOI | None listed |
| Oct 30, 2020 | Luminex Corporation Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024 Open, Classified |
OCC | None listed |
| Oct 13, 2020 | Luminex Corporation Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, whi Terminated |
PAM | None listed |
| Oct 13, 2020 | Luminex Corporation Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, whi Terminated |
PEN | None listed |
| Dec 10, 2018 | Luminex Corporation VERIGENE Processor SP
Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids Open, Classified |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.