510(k) K992662 ยท MSJ Apolipoproteins
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Feb 15, 2000 |
| Received | Aug 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992662
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2024 | Siemens Healthcare Diagnostics, Inc. Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Open, Classified |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.