510(k) K800853 ยท JBD System, Analysis, Electrophoretic Hemoglobin
A,SA2 LYOPHILIZED HEMO CONTROL
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 29, 1980 |
| Received | Apr 15, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800853
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.