Home / Companies / Nichols Institute Diagnostics

Nichols Institute Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
68
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYJune 1, 2005
K042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYDecember 17, 2004
K042689NICHOLS ADVANTAGE CORTISOLDecember 9, 2004
K040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022June 8, 2004
K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYApril 22, 2004
K033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040January 26, 2004
K032188NICHOLS ADVANTAGE ALDOSTERONE ASSAYJuly 31, 2003
K022356NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAYOctober 25, 2002
K022472PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)October 9, 2002
K013992NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAYDecember 13, 2001
K012367VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN DOctober 9, 2001
K011128NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)September 6, 2001
K002888NICHOLS ADVANTAGE THYROGLOBOctober 20, 2000
K994140NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240May 9, 2000
K992188NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028December 6, 1999
K980737ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYMarch 23, 1999
K984520NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005February 5, 1999
K984186NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAYFebruary 2, 1999
K983992NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAYJanuary 26, 1999
K982866NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521October 16, 1998