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Sekisui Diagnostics LLC

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) an recall (Z-0015-2014)Sekisui Diagnostics LLC2013-10-17
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determ recall (Z-0463-2013)Sekisui Diagnostics Llc2012-12-03
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminog recall (Z-2431-2012)Sekisui Diagnostics Llc2012-09-20
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended recall (Z-1902-2012)Sekisui Diagnostics Llc2012-06-27

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