510(k) K131930 ยท NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
JBAIDS ANTHRAX DETECTION KIT
| Applicant | Biofire Diagnostics, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Aug 5, 2013 |
| Received | Jun 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131930
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2014 | Biofire Defense JBAIDS Instrument System Software version 3.5.0.72.
The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological Terminated |
NHT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.