FDA 510(k) Applications Submitted by JIMMY WONG

FDA 510(k) Number Submission Date Device Name Applicant
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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact