510(k) K952466 ยท JHN Turbidimetric Method, Lipoproteins
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Jun 5, 1995 |
| Received | May 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952466
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2025 | Beckman Coulter Ireland, Inc. Apo B Reagent, REF: OSR6143 Open, Classified |
JHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.