510(k) K111387 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
| Applicant | Iquum, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Aug 4, 2011 |
| Received | May 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2021 | Roche Molecular Systems, Inc. cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 Open, Classified |
OOI | None listed |
| Jul 13, 2016 | Roche Molecular Systems, Inc. cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay. Terminated |
OCC | None listed |
| May 9, 2016 | Roche Molecular Systems, Inc. cobas Liat Analyzer Terminated |
OCC | None listed |
| Sep 2, 2015 | Roche Molecular Systems, Inc. cobas Liat Analyzer, for in vitro diagnostic use. Terminated |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.