510(k) K110035 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
INDIKO
| Applicant | Thermofisher Scientific OY, Vantaa, FI |
| Decision | Substantially Equivalent, Jun 28, 2011 |
| Received | Jan 5, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110035
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2015 | The Binding Site Group, Ltd. Optilite Analyser, Product Code: IE700
Product Usage:
The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that m Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.