510(k) K091361 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
| Applicant | Siemens Healthcare Diagnostics, Suwanee GA, US |
| Decision | Substantially Equivalent, Dec 16, 2009 |
| Received | May 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Siemens Healthcare Diagnostics Products Ltd. Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF:L2KSY2(D)/10471981
IVD, RxOnly Open, Classified |
LIP | None listed |
| Aug 14, 2026 | Siemens Healthcare Diagnostics Products Ltd. Siemens Healthineers
Immulite 2000 Systems SYP Syphilis Screen
REF(s):L2kSY2/10489085; L2KSY6/10488319
IVD, RxOnly Open, Classified |
LIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.