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ELITech Clinical Systems SAS

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Eon 100 system included the following product reference numbers and names: Reference no. 7 recall (Z-0214-2016)ELITech Clinical Systems SAS2015-11-05
Eon 300 system includes the following product reference numbers and names: Reference no. 7 recall (Z-0215-2016)ELITech Clinical Systems SAS2015-11-05
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize recall (Z-0216-2016)ELITech Clinical Systems SAS2015-11-05
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 5 recall (Z-0217-2016)ELITech Clinical Systems SAS2015-11-05
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of t recall (Z-0006-2015)ELITech Clinical Systems SAS2014-10-02

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Every clearance here is in the API, with alerts when new ones post.