510(k) K832713 ยท JJW Urinalysis Controls (Assayed And Unassayed)
IRI SPEC URINALYSIS CONTROL
| Applicant | Intl. Remote Imaging Systems, Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 22, 1983 |
| Received | Aug 12, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832713
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2013 | Iris Diagnostics Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12.
Product Usage: For in vitro diagnostic use with the iQ200 series. Terminated |
JJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.