510(k) K980996 ยท KHS Enzymatic, Carbon-Dioxide
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jun 5, 1998 |
| Received | Mar 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980996
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.