510(k) K063206 ยท LPS Urinary Homocystine (Nonquantitative) Test System
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Dec 28, 2006 |
| Received | Oct 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063206
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2016 | CSL Behring GmbH Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, hepariniz Terminated |
LPS | None listed |
| Dec 19, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista Homocysteine Flex Reagent Cartridge
The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma an Terminated |
LPS | None listed |
| Nov 6, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge
This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, Terminated |
LPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.