JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Boehringer Mannheim Corp. and Roche Diagnostics Corp..

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
25–48 of 673
Cleared Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
K021381
Dade Behring, Inc.
Immunology · 40d
Cleared Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
K020521
Beckman Coulter, Inc.
Chemistry · 10d
Cleared Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
K013235
Beckman Coulter, Inc.
Chemistry · 18d
Cleared Sep 04, 2001
MODIFICATION TO N/T PROTEIN CONTROL SL
K012468
Dade Behring, Inc.
Chemistry · 33d
Cleared Aug 29, 2001
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642
K012513
Bio-Rad
Chemistry · 23d
Cleared Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
K011853
Bio-Rad
Immunology · 34d
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867
Bio-Rad
Chemistry · 28d
Cleared Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
K011579
Bio-Rad
Immunology · 35d
Cleared Jun 08, 2001
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL
K011494
Bio-Rad
Immunology · 24d
Cleared Mar 05, 2001
VIGIL SEROLOGY CONTROL LEVEL C
K010358
Beckman Coulter, Inc.
Immunology · 27d
Cleared Nov 27, 2000
N/T PROTEIN CONTROL SL
K002852
Dade Behring, Inc.
Chemistry · 75d
Cleared Nov 27, 2000
SYNCHRON CONTROL
K003488
Beckman Coulter, Inc.
Toxicology · 14d
Cleared Aug 31, 2000
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
K002460
Bio-Rad
Chemistry · 21d
Cleared Aug 07, 2000
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
K002196
Bio-Rad
Chemistry · 18d
Cleared May 25, 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K001373
Bio-Rad
Chemistry · 24d
Cleared Apr 20, 2000
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
K000875
Bio-Rad
Chemistry · 31d
Cleared Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
K000270
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Nov 30, 1999
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
K993310
Dade Behring, Inc.
Chemistry · 57d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
K993023
Beckman Coulter, Inc.
Immunology · 78d
Cleared Nov 24, 1999
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
K992710
Abbott Laboratories
Immunology · 105d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
K992900
Roche Diagnostics Corp.
Immunology · 86d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K993360
Roche Diagnostics Corp.
Immunology · 49d
Cleared Nov 09, 1999
LYPHOCHEK ANEMIA CONTROL, MODEL 500
K992741
Bio-Rad
Immunology · 85d
Cleared Sep 02, 1999
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
K992172
Bio-Rad
Chemistry · 66d