510(k) K021206 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
IMMULITE 2000 SPECIFIC ALLERGENS
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, May 30, 2002 |
| Received | Apr 16, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021206
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2025 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Oak Mix Specific Allergen;
Siemens Material Number (SMN): 10386105;
Catalog Number: L2KUN6; Open, Classified |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.