510(k) K072640 ยท JJW Urinalysis Controls (Assayed And Unassayed)
IRISPEC,CA/CB/CC
| Applicant | Iris Diagnostics, Chatsworth CA, US |
| Decision | Substantially Equivalent, Dec 21, 2007 |
| Received | Sep 18, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K072640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2024 | Beckman Coulter, Inc. Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device. Open, Classified |
JJW | None listed |
| Jan 3, 2023 | Beckman Coulter, Inc. BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic
use only. Open, Classified |
JJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.