510(k) K963498 ยท JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
FERR FLEX REAGENT CARTRIDGE
| Applicant | Dade Chemistry Systems, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 24, 1997 |
| Received | Sep 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2019 | Siemens Healthcare Diagnostics, Inc. Dimension Ferritin (FERR) Flex reagent cartridge
DM FERR
Product Usage:
The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure Terminated |
JMG | None listed |
| Aug 15, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses Terminated |
JMG | None listed |
| Dec 24, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052
Product Usage: Used in the Dimension(R) system with the heterogeneous module Terminated |
JMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.