510(k) K861700 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Jun 11, 1986 |
| Received | May 5, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861700
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Siemens Healthcare Diagnostics, Inc. Dimension Magnesium (MG) Flex reagent cartridge
Siemens
Material Number (SMN)/REF (Catalog Number):10444963/DF57 Open, Classified |
JGJ | None listed |
| Apr 2, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)
The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the Terminated |
CEO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.