510(k) K021163 ยท MRG System, Test, Vitamin D
OCTEIA 25-HYDROXY VITAMIN D
| Applicant | Immunodiagnostic Systems , Ltd., Boldon, Tyne & Wear, GB |
| Decision | Substantially Equivalent, May 10, 2002 |
| Received | Apr 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2013 | IDS (Immunodiagnostic Systems Ltd.) 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1.
Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) a Terminated |
MRG | None listed |
| Oct 24, 2008 | Immunodiagnostics Systems Inc IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Terminated |
MRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.