510(k) K964560 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
BHI W/VANCOMYCIN AGAR
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Jan 15, 1997 |
| Received | Nov 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964560
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2020 | Hardy Diagnostics Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml Terminated |
JSO | None listed |
| Aug 29, 2006 | Hardy Media Inc Dba Hardy Diag BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136 Terminated |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.