510(k) K123343 ยท MLM Enzyme Immunoassay, Tracrolimus
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
| Applicant | Microgenics Corp., Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, Jul 11, 2013 |
| Received | Oct 31, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123343
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2024 | Ortho-Clinical Diagnostics, Inc. QMS Tacrolimus Calibrators, Product code 10015573 Open, Classified |
JIT | None listed |
| Jan 20, 2022 | Microgenics Corporation QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET
QMS TACROLIMUS CAL A 10015566-3
QMS TACROLIMUS CAL B 10015567-3
QMS TACROLIMUS CAL C 10015568-3
QMS TACROLIMUS CAL D 10015569-3
QMS TACROLIMUS C Open, Classified |
MLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.