510(k) K040471 ยท JIT Calibrator, Secondary
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Mar 10, 2004 |
| Received | Feb 24, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2026 | Beckman Coulter Ireland, Inc. The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol Open, Classified |
LBS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.