510(k) K974607 ยท CJY Azo Dye, Calcium
RANDOX CALCIUM
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, IE |
| Decision | Substantially Equivalent, Feb 2, 1998 |
| Received | Dec 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2018 | Randox Laboratories Ltd. Randox CALCIUM (Ca) Colorimetric Method RX Series
Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml
GTIN: 05055273200904 Terminated |
CJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.