FDA 510(k) Applications Submitted by NICHOLS INSTITUTE DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K980716 01/07/1998 ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K961650 04/30/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT NICHOLS INSTITUTE DIAGNOSTICS
K961678 05/01/1996 HUMAN GROWTH HORMONE IMMUNOASSAY KIT NICHOLS INSTITUTE DIAGNOSTICS
K962033 05/24/1996 CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT NICHOLS INSTITUTE DIAGNOSTICS
K972070 06/03/1997 NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS NICHOLS INSTITUTE DIAGNOSTICS
K962208 06/10/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT NICHOLS INSTITUTE DIAGNOSTICS
K962408 06/21/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT NICHOLS INSTITUTE DIAGNOSTICS
K962601 07/02/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE NICHOLS INSTITUTE DIAGNOSTICS
K962598 07/02/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT NICHOLS INSTITUTE DIAGNOSTICS
K962687 07/11/1996 GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K964635 11/19/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT NICHOLS INSTITUTE DIAGNOSTICS
K965058 12/18/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT NICHOLS INSTITUTE DIAGNOSTICS
K961142 03/21/1996 STRATEC LIA II ANALYZER NICHOLS INSTITUTE DIAGNOSTICS
K992188 06/29/1999 NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 NICHOLS INSTITUTE DIAGNOSTICS
K022356 07/19/2002 NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K984520 12/21/1998 NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 NICHOLS INSTITUTE DIAGNOSTICS
K980737 02/25/1998 ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K040813 03/30/2004 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 NICHOLS INSTITUTE DIAGNOSTICS
K011128 04/13/2001 NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) NICHOLS INSTITUTE DIAGNOSTICS
K032188 07/17/2003 NICHOLS ADVANTAGE ALDOSTERONE ASSAY NICHOLS INSTITUTE DIAGNOSTICS
K012367 07/26/2001 VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D NICHOLS INSTITUTE DIAGNOSTICS
K022472 07/26/2002 PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) NICHOLS INSTITUTE DIAGNOSTICS
K982866 08/14/1998 NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 NICHOLS INSTITUTE DIAGNOSTICS
K002888 09/15/2000 NICHOLS ADVANTAGE THYROGLOB NICHOLS INSTITUTE DIAGNOSTICS
K042689 09/29/2004 NICHOLS ADVANTAGE CORTISOL NICHOLS INSTITUTE DIAGNOSTICS
K033302 10/14/2003 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 NICHOLS INSTITUTE DIAGNOSTICS
K983992 11/09/1998 NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY NICHOLS INSTITUTE DIAGNOSTICS
K984186 11/23/1998 NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K994140 12/08/1999 NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 NICHOLS INSTITUTE DIAGNOSTICS
K013992 12/04/2001 NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K033727 11/28/2003 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K050784 03/28/2005 NICHOLS ADVANTAGE ALDOSTERONE ASSAY NICHOLS INSTITUTE DIAGNOSTICS
K042676 09/29/2004 NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY NICHOLS INSTITUTE DIAGNOSTICS


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