510(k) K062024 ยท LFM Enzyme Immunoassay, Digitoxin
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 28, 2006 |
| Received | Jul 18, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275. Terminated |
LCD | None listed |
| Apr 19, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and
17312BB. Terminated |
LCD | None listed |
| Nov 20, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071)
The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum a Terminated |
KLS | None listed |
| Mar 21, 2011 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012
This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human Terminated |
LCD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.