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Nichols Institute Diagnostics

FDA 510(k) & PMA Approved Devices — 68 products

Total Devices68
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K050784 NICHOLS ADVANTAGE ALDOSTERONE ASSAYCJM2005-06-01 View
510(k) K042676 NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYDHA2004-12-17 View
510(k) K042689 NICHOLS ADVANTAGE CORTISOLCGR2004-12-09 View
510(k) K040813 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022CEW2004-06-08 View
510(k) K033727 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYCEW2004-04-22 View
510(k) K033302 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040CEW2004-01-26 View
510(k) K032188 NICHOLS ADVANTAGE ALDOSTERONE ASSAYCJM2003-07-31 View
510(k) K022356 NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAYLYR2002-10-25 View
510(k) K022472 PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)CEW2002-10-09 View
510(k) K013992 NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAYCEW2001-12-13 View
510(k) K012367 VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN DJIT2001-10-09 View
510(k) K011128 NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)CIB2001-09-06 View
510(k) K002888 NICHOLS ADVANTAGE THYROGLOBMSW2000-10-20 View
510(k) K994140 NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240MSW2000-05-09 View
510(k) K992188 NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028JNM1999-12-06 View
510(k) K980737 ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYGGT1999-03-23 View
510(k) K984520 NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005CGR1999-02-05 View
510(k) K984186 NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAYDBF1999-02-02 View
510(k) K983992 NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAYJZO1999-01-26 View
510(k) K982866 NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521JZO1998-10-16 View
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