510(k) K010429 ยท MMI Immunoassay Method, Troponin Subunit
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 5, 2001 |
| Received | Feb 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2011 | Beckman Coulter Inc. Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803
The Access Accu Tri assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of c Terminated |
MMI | None listed |
| Jul 12, 2010 | Beckman Coulter Inc. Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803
The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ca Terminated |
MMI | None listed |
| Apr 12, 2010 | Beckman Coulter Inc. Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345
The intended Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.