BD Phoenix Automated Microbiology System – GN Eravacycline (0.125-2 µg/mL) (K251713)
Description
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) by Becton, Dickinson and Company, an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251713
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BD Phoenix Automated Microbiology System – GN Eravacycline (0.125-2 µg/mL) (K251713) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K132909 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-... | Becton, Dickinson and Company | 2014 |
Trace the full predicate network for K251713
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.