510(k) K123364 ยท MRG System, Test, Vitamin D
25OH VITAMIN D TOTAL ELISA TEST
| Applicant | Diasource Immunoassays, S.A., Davis CA, US |
| Decision | Substantially Equivalent, Jul 15, 2013 |
| Received | Nov 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2018 | R & D Systems, Inc. R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 Terminated |
MRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.