510(k) K923506 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
UREA KIT
| Applicant | Randox Laboratories, Ltd., Antrim, N. Ireland, IR |
| Decision | Substantially Equivalent, Sep 27, 1993 |
| Received | Jul 15, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923506
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2023 | Randox Laboratories Ltd. Randox RX Series Urea Enzymatic Kinetic Assay
Ref. Numbers:
(1) UR3825
(2) UR3873
(3) UR8334
(4) UR8070 (Modena) Open, Classified |
CDQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.