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. |
K051297 |
05/18/2005 |
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK |
ROCHE DIAGNOSTICS CORP. |
K051292 |
05/18/2005 |
ELECSYS RBC FOLATE HEMOLYZED REAGENT |
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. |
K003411 |
11/02/2000 |
ELECSYS TESTOSTERONE CALSET II |
ROCHE DIAGNOSTICS CORP. |
K003409 |
11/02/2000 |
ELECSYS FSH 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. |
K003969 |
12/22/2000 |
ELECSYS CA 125 II CALSET |
ROCHE DIAGNOSTICS CORP. |
K003967 |
12/22/2000 |
CA 125 II CALCHECK |
ROCHE DIAGNOSTICS CORP. |
K042490 |
09/14/2004 |
ELECSYS FOLATE II CALSET II |
ROCHE DIAGNOSTICS CORP. |