510(k) K911838 ยท CHS Coulometric Method, Carbon-Dioxide
ROCHE REAGENT FOR C02
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Jul 19, 1991 |
| Received | Apr 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911838
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.