510(k) K141289 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
| Applicant | Teco Diagnostics, Anaheim CA, US |
| Decision | Substantially Equivalent, Jul 24, 2015 |
| Received | May 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141289
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.