510(k) K112343 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 20, 2012 |
| Received | Aug 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112343
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2021 | Siemens Healthcare Diagnostics, Inc Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Cent Open, Classified |
LIP | None listed |
| Aug 20, 2012 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack
Reference Number 10492493
Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitati Terminated |
LIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.