510(k) K962819 ยท LCD Enzyme Immunoassay, Gentamicin
GENTAMICIN FLEX REAGENT CARTRIDGE
| Applicant | Dade Intl., Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 13, 1996 |
| Received | Jul 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962819
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.