510(k) K100525 ยท CGA Glucose Oxidase, Glucose
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
| Applicant | Seppim S.A.S., Bothell WA, US |
| Decision | Substantially Equivalent, Dec 15, 2010 |
| Received | Feb 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2015 | ELITech Clinical Systems SAS Eon 100 system included the following product reference numbers and names:
Reference no. 77345- Glucose (GPSL)
Reference no. 77450- Uric acid (AUVD)
Reference no. 77435- Triglycerides (TGML)
Refere Terminated |
CGA | None listed |
| Nov 5, 2015 | ELITech Clinical Systems SAS Eon 300 system includes the following product reference numbers and names:
Reference no. 79345 Glucose (GPSL)
Reference no. 79450 Uric acid (AUVD)
Reference no. 79435 Triglycerides (TGML)
Reference Terminated |
CGA | None listed |
| Nov 5, 2015 | ELITech Clinical Systems SAS ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method.
The following product reference numbers and names:
GPSL-025O: Glucose PAP SL
A Terminated |
CGA | None listed |
| Nov 5, 2015 | ELITech Clinical Systems SAS Envoy 500 system includes the following product reference numbers and names:
55345 ENVOY 500 Glucose
55450 ENVOY 500 URIC ACID REAGENT KIT
55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT,
55297 ENVOY 500 Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.