510(k) K801243 ยท CDO Acid, Uric, Uricase (U.V.)
COBAS REAGENTS FOR URIC ACID
| Applicant | Roche Analytical Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 26, 1980 |
| Received | May 27, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801243
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.