510(k) K001647 ยท JZW Nephelometer
BN PROSPEC SYSTEM
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Sep 26, 2000 |
| Received | May 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001647
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2019 | Siemens Healthcare Diagnostics, Inc. N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF.
Siemens Material Number (SMN):10446539 Terminated |
JZW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.