510(k) K002674 ยท DDZ Albumin, Fitc, Antigen, Antiserum, Control
RANDOX MICROALBUMIN
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, IE |
| Decision | Substantially Equivalent, Oct 5, 2000 |
| Received | Aug 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002674
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2024 | Randox Laboratories Ltd. Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay
Catalog Number: MA2426 Open, Classified |
DDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.