510(k) K983848 ยท DDR Myoglobin, Antigen, Antiserum, Control
ABBOTT AXSYM MYOGLOBIN
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 16, 1998 |
| Received | Oct 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983848
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2009 | Abbott Laboratories AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or Terminated |
DDR | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
DDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.