510(k) K102647 ยท JGS Electrode, Ion Specific, Sodium
ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
| Applicant | Elitechgroup Vital Scientific BV, Bothell WA, US |
| Decision | Substantially Equivalent, Mar 24, 2011 |
| Received | Sep 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102647
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2016 | ELITech Group B.V. Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratorie Terminated |
JJE | None listed |
| Oct 2, 2014 | ELITech Clinical Systems SAS ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500.
Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate a Terminated |
CIT | None listed |
| Jan 10, 2012 | Vital Scientific N.V. Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401
Product Usage: :clinical chemistry system intended for use in clinical laboratories. Terminated |
JGS | None listed |
| Jan 10, 2012 | Vital Scientific N.V. Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418
Product Usage: :clinical chemistry system intended for use in clinical laboratories. Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.