510(k) K013134 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 15, 2001 |
| Received | Sep 19, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013134
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit Terminated |
DHB | None listed |
| Jun 25, 2015 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD.
For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzer Terminated |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.