JJY · Class I · 21 CFR 862.1660

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

Leading manufacturers include Bio-Rad, Medical Analysis Systems, Inc. and Cliniqa Corporation.

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
169–192 of 673
Cleared Oct 02, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE
K022936
Cliniqa Corporation
Chemistry · 28d
Cleared Sep 27, 2002
PH AND AMINES EXTERNAL CONTROL SET
K022851
Quidel Corp.
Chemistry · 31d
Cleared Sep 17, 2002
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593
K022991
Bio-Rad
Immunology · 8d
Cleared Aug 30, 2002
RANDOX LIPID CONTROL
K022591
Randox Laboratories, Ltd.
Chemistry · 25d
Cleared Aug 21, 2002
PTS PANELS MULTI-CHEMISTRY CONTROLS
K022401
Polymer Technology Systems, Inc.
Chemistry · 29d
Cleared Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
K022041
Bio-Rad Laboratories, Inc.
Immunology · 22d
Cleared Jun 25, 2002
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
K021930
Bionostics, Inc.
Chemistry · 13d
Cleared Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
K021381
Dade Behring, Inc.
Immunology · 40d
Cleared Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
K020817
Bio-Rad Laboratories, Inc.
Chemistry · 30d
Cleared Mar 21, 2002
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET
K020450
Maine Standards Co.
Chemistry · 38d
Cleared Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
K020521
Beckman Coulter, Inc.
Chemistry · 10d
Cleared Dec 21, 2001
MODIFICATION TO MAS CARDIOLMMUNE TL
K013995
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared Dec 07, 2001
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL
K013734
Medical Analysis Systems, Inc.
Chemistry · 24d
Cleared Nov 20, 2001
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
K013265
Maine Standards Co.
Chemistry · 50d
Cleared Nov 20, 2001
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
K013332
Cliniqa Corporation
Immunology · 42d
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 Aug 28, 2001
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
K012431
Bionostics, Inc.
Chemistry · 28d
Cleared Aug 20, 2001
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
K012117
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
K012118
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
K012119
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
K012120
Maine Standards Co.
Chemistry · 45d
Cleared Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
K011853
Bio-Rad
Immunology · 34d