510(k) K012367 ยท JIT Calibrator, Secondary
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
| Applicant | Nichols Institute Diagnostics, San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Oct 9, 2001 |
| Received | Jul 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2005 | Nichols Institute Diagnostics Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. Terminated |
MRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.