510(k) K033548 ยท KHE Reagent, Occult Blood
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 24, 2003 |
| Received | Nov 12, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033548
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2018 | Roche Diagnostics Corporation Roche Diagnostics URISYS 1100 Urine Analyzer
Part Number: 03617556001
Product Usage:
The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results Terminated |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.