FDA 510(k) Applications Submitted by NICHOLS INSTITUTE DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K780048 01/09/1978 AMINOGLYCOSIDE TEST SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K840379 01/27/1984 PARATHYROID HORMONE ANALYSIS PRODUCT NICHOLS INSTITUTE DIAGNOSTICS
K770854 05/09/1977 LUTEINIZING HORMONE RIA REAGENT, LH-RIA NICHOLS INSTITUTE DIAGNOSTICS
K842010 05/17/1984 THYROXINE-BINDING GLOBULIN RADIOUMMU NICHOLS INSTITUTE DIAGNOSTICS
K842907 07/24/1984 CALCITONIN RADIOIMMUNOASSAY KIT NICHOLS INSTITUTE DIAGNOSTICS
K771756 09/16/1977 FOLLICLE-STIMULATING HORMONE NICHOLS INSTITUTE DIAGNOSTICS
K771783 09/23/1977 PTH RIA NICHOLS INSTITUTE DIAGNOSTICS
K833471 10/06/1983 ADRENOCOR TICOTROPIC HORMONE RADIOIMM NICHOLS INSTITUTE DIAGNOSTICS
K772116 11/07/1977 AMINOGLYCOSIDE TEST SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K782010 12/01/1978 HORMONE KIT, PARATHYROID NICHOLS INSTITUTE DIAGNOSTICS
K925702 11/12/1992 NICHOLS APO B CHEMILUMINESCENCE ASSAY NICHOLS INSTITUTE DIAGNOSTICS
K926220 12/10/1992 T3 UPTAKE CHEMILUMINESCENCE ASSAY NICHOLS INSTITUTE DIAGNOSTICS
K923015 06/22/1992 TOTAL T3 CHEMILUMINESCENCE ASSAY NICHOLS INSTITUTE DIAGNOSTICS
K980716 01/07/1998 ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K950921 03/01/1995 CHEMILUMINESCENCE TSH 3RD GENERATION 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
K962598 07/02/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT NICHOLS INSTITUTE DIAGNOSTICS
K962601 07/02/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE NICHOLS INSTITUTE DIAGNOSTICS
K962687 07/11/1996 GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K954418 09/22/1995 INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) NICHOLS INSTITUTE DIAGNOSTICS
K935319 10/20/1993 CHEMILUMINESCENCE LH NICHOLS INSTITUTE DIAGNOSTICS
K964635 11/19/1996 NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT NICHOLS INSTITUTE DIAGNOSTICS
K945961 12/07/1994 CALCITONIN IMMUNOASSAY 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
K851259 03/28/1985 HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT NICHOLS INSTITUTE DIAGNOSTICS
K860851 03/07/1986 ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K841088 03/13/1984 SOMATOMEDIN-C RADIOIMMUNOASSAY KIT NICHOLS INSTITUTE DIAGNOSTICS
K881123 03/16/1988 ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. NICHOLS INSTITUTE DIAGNOSTICS
K881124 03/16/1988 ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K861797 05/09/1986 ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS
K872390 06/19/1987 ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K882741 07/01/1988 ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES NICHOLS INSTITUTE DIAGNOSTICS
K853717 09/05/1985 ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K843685 09/18/1984 C-TERMINAL/MID-MOLECULE PARATHYROID - NICHOLS INSTITUTE DIAGNOSTICS
K863678 09/19/1986 FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K863679 09/19/1986 ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K874572 11/05/1987 ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K854805 12/02/1985 ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM 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
K950029 01/04/1995 5STRATEC SL 300 LIA-MAT 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
K925998 11/27/1992 ACTIVE RENIN IMMUNORADIOMETRIC ASSAY NICHOLS INSTITUTE DIAGNOSTICS
K896222 10/30/1989 FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT NICHOLS INSTITUTE DIAGNOSTICS
K896808 12/04/1989 IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I 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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