510(k) K964635 ยท JKR Radioimmunoassay, Calcitonin
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
| Applicant | Nichols Institute Diagnostics, San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, May 21, 1997 |
| Received | Nov 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964635
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.