510(k) K083445 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Mar 24, 2009 |
| Received | Nov 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083445
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2022 | SIEMENS HEALTHCARE DIAGNOSTICS INC N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD
Siemens Material Number (SMN): 10446297 Open, Classified |
CFN | None listed |
| Oct 14, 2022 | SIEMENS HEALTHCARE DIAGNOSTICS INC N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD
Siemens Material Number (SMN): 10446299 Open, Classified |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.