510(k) K032014 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
N LATEX IGM
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 7, 2003 |
| Received | Jun 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032014
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2015 | Siemens Healthcare Diagnostics, Inc. N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry u Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.