510(k) K113793 ยท LPS Urinary Homocystine (Nonquantitative) Test System
HOMOCYSTEINE TEST
| Applicant | Roche, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 5, 2012 |
| Received | Dec 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113793
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2024 | Roche Diagnostics Operations, Inc. cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine Open, Classified |
LPS | None listed |
| Oct 4, 2019 | Roche Diagnostics Operations, Inc. Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems
Catalog Number: 06542921190 - - Product Usage: Terminated |
LPS | None listed |
| May 15, 2015 | Roche Diagnostics Operations, Inc. Homocysteine test system - Homocysteine Reagent.
05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA
Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of tot Terminated |
LPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.