510(k) K083463 ยท JZG System, Test, Beta-2-Microglobulin Immunological
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Mar 13, 2009 |
| Received | Nov 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD Terminated |
CHN | None listed |
| May 23, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD Terminated |
CHN | None listed |
| Mar 1, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System
B2 Microglobulin Flex reagent cartridge and urine stabilizer
Catalog #K7024 SMN: 10445889 Lot #15246MA
Product Usage:
The B2MIC method is an in vitro diagnostic test for th Terminated |
JZG | None listed |
| Aug 22, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC);
Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-Microglobulin in human serum, Terminated |
JZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.