510(k) K060280 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
ICHEM 100 URINE CHEMISTRY ANALYZER
| Applicant | Iris International, Inc., Chatsworth CA, US |
| Decision | Substantially Equivalent, Jun 13, 2006 |
| Received | Feb 2, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060280
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2014 | Beckman Coulter Inc. iChem 10 SG Urine Chemistry Strips, PN 800-7005.
Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, Terminated |
JIL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.