510(k) K990222 ยท DHA System, Test, Human Chorionic Gonadotropin
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Feb 26, 1999 |
| Received | Jan 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6] Open, Classified |
DHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.