510(k) K192271 ยท PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Access PCT, Access PCT Calibrators
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Nov 26, 2019 |
| Received | Aug 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192271
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | Beckman Coulter Inc. Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems Open, Classified |
PTF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.