510(k) K182042 ยท CJY Azo Dye, Calcium
Randox Calcium (Ca)
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Oct 23, 2018 |
| Received | Jul 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182042
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2018 | Randox Laboratories Ltd. Randox CALCIUM (Ca) COLORIMETRIC METHOD
RX DAYTONA PLUS
Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml
GTIN: 05055273208368 Terminated |
CJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.