FDA 510(k) Applications Submitted by KAY A TAYLOR

FDA 510(k) Number Submission Date Device Name Applicant
K100101 01/13/2010 GSP NEONATALGALT KIT, MODEL 3303-001U PERKINELMER, INC.
K070391 02/09/2007 ELECSYS PTH TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K100682 03/10/2010 GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U WALLAC OY
K070709 03/14/2007 ROCHE ELECSYS PTH TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K070788 03/22/2007 ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics
K001846 06/19/2000 ELECSYS INSULIN CALCHECK ROCHE DIAGNOSTICS CORP.
K072437 08/23/2007 ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET Roche Diagnostics
K093916 12/22/2009 NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U PERKINELMER, INC.
K000155 01/19/2000 ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K090123 01/21/2009 NEONATAL BIOTINIDASE KIT, MODEL 3018 PERKINELMER, INC.
K080147 01/22/2008 ELECSYS PROBNP II CALCHECK ROCHE DIAGNOSTICS CORP.
K050231 01/26/2005 ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET ROCHE DIAGNOSTICS CORP.
K050387 02/15/2005 ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR ROCHE DIAGNOSTICS CORP.
K000534 02/17/2000 COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II ROCHE DIAGNOSTICS CORP.
DEN140010 02/19/2014 PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM WALLAC OY
K000568 02/22/2000 HDL CHOLESTEROL PLUS ROCHE DIAGNOSTICS CORP.
K000576 02/22/2000 ELECSYS CORTISOL CALCHECK ROCHE DIAGNOSTICS CORP.
K010588 02/27/2001 ELECSYSCA 15-3 II ASSAY ROCHE DIAGNOSTICS CORP.
K010978 03/13/2001 TINA-QUANT ALPHA-1 ANTITRYPSIN ROCHDIAG
K060754 03/21/2006 ELECSYS TSH CALSET W/MODELS 04738551 ROCHE DIAGNOSTICS CORP.
K001014 03/29/2000 ELECSYS ANTI-TPO CALCHECK ROCHE DIAGNOSTICS CORP.
K001015 03/29/2000 ELECSYS THYROGLOBULIN CALCHECK ROCHE DIAGNOSTICS CORP.
K090846 03/30/2009 GSP INSTRUMENT AND GSP NEONATAL HTSH KIT PERKINELMER, INC.
K011143 04/13/2001 TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K011226 04/20/2001 CALIBRATOR FOR AUTOMATED SYSTEMS ROCHE DIAGNOSTICS CORP.
K051292 05/18/2005 ELECSYS RBC FOLATE HEMOLYZED REAGENT ROCHE DIAGNOSTICS CORP.
K051297 05/18/2005 ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK ROCHE DIAGNOSTICS CORP.
K031650 05/28/2003 FERRITIN GENERATION 2 ROCHE DIAGNOSTICS CORP.
K001906 06/22/2000 ELECSYS INSULIN CALSET ROCHE DIAGNOSTICS CORP.
K121864 06/26/2012 PERKINELMER 226 SAMPLE COLLECTION DEVICES PERKINELMER, INC.
K051890 07/12/2005 ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ROCHE DIAGNOSTICS CORP.
K061970 07/12/2006 ELECSYS IGE II IMMUNOASSAY Roche Diagnostics
K012397 07/27/2001 URISYS 2400 URINE TEST STRIP ROCHE DIAGNOSTICS CORP.
K002353 08/02/2000 ELECSYS CA 15-3 CALCHECK ROCHE DIAGNOSTICS CORP.
K122495 08/16/2012 PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR PERKINELMER, INC.
K002609 08/22/2000 TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K032646 08/27/2003 ELECSYS PROBNP IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K002706 08/30/2000 ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI ROCHE DIAGNOSTICS CORP.
K002760 09/05/2000 ELECSYS DHEA-S CALSET ROCHE DIAGNOSTICS CORP.
K013206 09/25/2001 TINA-QUANT APOLIPOPROTEIN B VER.2 ROCHE DIAGNOSTICS CORP.
K013207 09/25/2001 TINA-QUANT APOLIPOPROTEIN B VER.2 ROCHE DIAGNOSTICS CORP.
K003064 10/02/2000 TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 ROCHE DIAGNOSTICS CORP.
K003120 10/05/2000 MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C ROCHE DIAGNOSTICS CORP.
K003174 10/10/2000 ELECSYS DHEA-S ROCHE DIAGNOSTICS CORP.
K003178 10/11/2000 ELECSYS HCG AND BETA TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K083130 10/23/2008 NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 PERKINELMER, INC.
K003400 11/01/2000 CRP HS TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K003409 11/02/2000 ELECSYS FSH CALSET II ROCHE DIAGNOSTICS CORP.
K003411 11/02/2000 ELECSYS TESTOSTERONE CALSET II ROCHE DIAGNOSTICS CORP.
K043095 11/09/2004 ROCHE DIAGNOSTICS ELECSYS AFP CALSET II ROCHE DIAGNOSTICS CORP.
K043175 11/16/2004 ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE ROCHE DIAGNOSTICS CORP.
K043318 12/02/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K043320 12/02/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II ROCHE DIAGNOSTICS CORP.
K003772 12/06/2000 ELECSYS DHEA-S CALCHECK ROCHE DIAGNOSTICS CORP.
K173829 12/18/2017 NeoLSD MSMS kit Wallac Oy, a subsidiary of PerkinElmer
K003941 12/21/2000 ELECSYS HCG STAT CLASET II ROCHE DIAGNOSTICS CORP.
K003967 12/22/2000 CA 125 II CALCHECK ROCHE DIAGNOSTICS CORP.
K003969 12/22/2000 ELECSYS CA 125 II CALSET ROCHE DIAGNOSTICS CORP.
K042490 09/14/2004 ELECSYS FOLATE II CALSET II ROCHE DIAGNOSTICS CORP.


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