510(k) K071811 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
ETOH FLEX REAGENT CARTRIDGE (DF22)
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 24, 2007 |
| Received | Jul 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071811
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use. Terminated |
DIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.