510(k) K945913 ยท JJW Urinalysis Controls (Assayed And Unassayed)
IRISPEC URINE CHEMISTRY CONTROL PART A AND B
| Applicant | International Remote Imaging Systems, Chartsworth CA, US |
| Decision | Substantially Equivalent, Apr 5, 1995 |
| Received | Dec 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945913
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2012 | Iris Diagnostics IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074.
Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes a Terminated |
JJW | None listed |
| Jun 11, 2005 | International Remote Imaging Systems Inc IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. Terminated |
JJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.