510(k) K150168 · MLM Enzyme Immunoassay, Tracrolimus
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Nov 4, 2015 |
| Received | Jan 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150168
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2026 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay Open, Classified |
MLM | None listed |
| Mar 15, 2023 | Siemens Healthcare Diagnostics, Inc. Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension clinical chemistry system
SMN: 10700795 Open, Classified |
MLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.