510(k) K020217 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 15, 2002 |
| Received | Jan 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387
For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems. Terminated |
CEW | None listed |
| Jun 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394.
For in vitro diagnostic use in calibrating Intact PTH assays. Terminated |
JIT | None listed |
| Jun 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628.
For in vitro diagnostic use in calibrating Intact PTH assays. Terminated |
JIT | None listed |
| Mar 7, 2012 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138)
Cat. Nos.
100 Test kit 04385983 (129501)
500 Test kit 06587575 (129502).
For in vitro diagnostic use in the quantitative determination of intact Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.