510(k) K142033 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
| Applicant | Nanospere,Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Oct 10, 2014 |
| Received | Jul 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142033
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2018 | Luminex Corporation Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-B Terminated |
PCH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.