510(k) K190553 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
HardyCHROM CRE
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, Apr 29, 2019 |
| Received | Mar 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2025 | Hardy Diagnostics HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323 Open, Classified |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.