510(k) K132462 ยท CDN Urease, Photometric, Urea Nitrogen
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
| Applicant | Hitachi Chemical Diagnostics, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 28, 2013 |
| Received | Aug 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132462
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.