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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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