510(k) K043546 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 18, 2005 |
| Received | Dec 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2023 | Siemens Healthcare Diagnostics, Inc. Aptio Automation Storage and Retrieval Module (SRM) Open, Classified |
JJE | None listed |
| Oct 6, 2021 | Siemens Healthcare Diagnostics, Inc. Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038 Open, Classified |
CDT | None listed |
| Mar 24, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for Terminated |
CDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.