510(k) K860021 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Feb 11, 1986 |
| Received | Jan 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860021
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2011 | Siemens Healthcare Diagnostics, Inc. Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of calcium activity in human serum, plasma an Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.