510(k) K963627 ยท JGS Electrode, Ion Specific, Sodium
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Oct 24, 1996 |
| Received | Sep 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963627
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.