510(k) K050374 ยท NDW Assay, Porphyrin, Spectrophotometry, Lithium
ADVIA IMS LITHIUM ASSAY
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 15, 2005 |
| Received | Feb 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050374
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay Open, Classified |
NDW | None listed |
| Oct 20, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay Open, Classified |
NDW | None listed |
| Feb 9, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 Open, Classified |
NDW | None listed |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Calibrator Terminated |
NDW | None listed |
| Oct 7, 2016 | Siemens Healthcare Diagnostics, Inc. Advia Chemistry Calibrator
For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_ Terminated |
JJY | None listed |
| Nov 19, 2013 | Siemens Healthcare Diagnostics Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD
Product usage: Usage: Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.