510(k) K021897 ยท LCP Assay, Glycosylated Hemoglobin
RANDOX HAEMOGLOBIN A1C
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Nov 26, 2002 |
| Received | Jun 10, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021897
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2017 | Randox Laboratories Ltd. Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.