510(k) K121214 ยท MMI Immunoassay Method, Troponin Subunit
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 14, 2013 |
| Received | Apr 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121214
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2025 | Beckman Coulter, Inc. Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901 Open, Classified |
JJE | None listed |
| Mar 17, 2025 | Beckman Coulter, Inc. Access 2 Immunoassay Analyzer, Catalog Number 81600N Open, Classified |
JJE | None listed |
| Dec 20, 2024 | Beckman Coulter, Inc. Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit.
For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma. Open, Classified |
MMI | None listed |
| Mar 15, 2023 | Beckman Coulter, Inc. Access Immunoassay Systems
(1) Access 2 Immunoassay Analyzer
(81600N);
(2) Access 2 Immunoassay Analyzer, Refurbished (386220);
(3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and
(4) Acces Open, Classified |
JJE | None listed |
| Nov 6, 2014 | Beckman Coulter Inc. Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A.
Product Usage:
The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitat Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.