510(k) K183432 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
cobas u 601 urinalysis test system
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 7, 2019 |
| Received | Dec 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183432
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2021 | Roche Diagnostics Operations, Inc. Cobas u 601 urinalysis test system, Catalog number 06334601001
The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyz Terminated |
KQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.