510(k) K033036 ยท MOI System, Test, Immunological, Antigen, Tumor
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Feb 3, 2004 |
| Received | Sep 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2017 | Beckman Coulter Inc. Access BR Monitor, Part No. 387620 Terminated |
MOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.