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Reference Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K053211RDI HSFERRITIN KITMarch 13, 2006
K053291FERRITIN CALIBRATOR SET, CATALOG NO. 8203March 13, 2006
K052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETNovember 9, 2005
K030044EXTENDED RANGE HS CRP KIT, CAT NO:9200September 30, 2003
K030772RDI EXTENDED RANGE CRP CALIBRATOR SETApril 11, 2003
K021607RDI HS CRP CALIBRATOR SETJune 27, 2002
K021609RDI HS CRP KITJune 27, 2002
K000783DIRECT TIBC CALIBRATORMay 4, 2000
K000781DIRECT TIBC KITMay 2, 2000
K990216MAGNETIC TIBC KITFebruary 16, 1999
K984107RDI DIRECT LDL CHOLESTEROL TESTJanuary 28, 1999
K973988RDI HOMOGENEOUS HDL CHOLESTEROL TESTDecember 22, 1997
K964063RDI LDL PRECIPITATION REAGENTNovember 20, 1996
K964064RDI LIPIDIRECT MAGNETIC LDL REAGENTNovember 20, 1996
K944975MAGNETIC HDL CHOLESTEROL TESTAugust 2, 1995
K911906MAGNETIC HDL CHOLESTEROL TESTJuly 18, 1991
K893740LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TESMarch 19, 1990