510(k) K974818 ยท MMI Immunoassay Method, Troponin Subunit
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Jan 16, 1998 |
| Received | Dec 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2011 | Radiometer America Inc Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) me Terminated |
JFP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.