510(k) K101572 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 1, 2011 |
| Received | Jun 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101572
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2025 | Siemens Healthcare Diagnostics, Inc. 3gAllergy Specific IgE Universal Kit;
Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2);
Siemens Material Number (SMN): 10380875;
Catal Open, Classified |
DHB | None listed |
| Dec 15, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US.
Siemens Material Number (SMN): 10708840
For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quan Open, Classified |
DHB | None listed |
| Dec 15, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan
Siemens Material Number (SMN): 10380875
For the quantitative measurement of allergen-specific IgE in human serum, Open, Classified |
DHB | None listed |
| Dec 15, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan
Siemens Material Number (SMN): 10711939
For the quantitative measurement of allergen-specific IgE in human serum, as an aid in Open, Classified |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.