510(k) K991094 ยท JZO System, Test, Thyroid Autoantibody
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, May 13, 1999 |
| Received | Apr 1, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991094
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2024 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody. Open, Classified |
JZO | None listed |
| May 23, 2024 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody. Open, Classified |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.