510(k) K801346 ยท GIF Diluent, Blood Cell
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA
| Applicant | Nobel Scientific Industries, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 12, 1980 |
| Received | Jun 9, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801346
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.