FDA 510(k) Applications Submitted by KATHIE J GOODWIN

FDA 510(k) Number Submission Date Device Name Applicant
K100538 02/25/2010 TINA-QUANT FERRITIN GEN. 4 Roche Diagnostics
K101203 04/29/2010 TINA-QUANT ALBUMIN GEN 2 Roche Diagnostics
K091741 06/16/2009 TINA-QUANT CERULOPLASMIN Roche Diagnostics
K082340 08/15/2008 ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS ROCHE DIAGNOSTICS CORP.
K092603 08/25/2009 COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY Roche Diagnostics
K102914 10/01/2010 TQ HBA1C GEN3 ROCHE
K083444 11/21/2008 C-REACTIVE PROTEIN (LATEX) ROCHE DIAGNOSTICS CORP.
K103716 12/21/2010 ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET Roche Diagnostics


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