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
145–168 of 673
Cleared Feb 28, 2001
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
K010111
Medical Analysis Systems, Inc.
Chemistry · 47d
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 Jul 05, 2000
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
K001758
Medical Analysis Systems, Inc.
Chemistry · 26d
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 Dec 20, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
K981915
The Binding Site, Ltd.
Immunology · 567d
Cleared Nov 30, 1999
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
K993310
Dade Behring, Inc.
Chemistry · 57d
Cleared Nov 30, 1999
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3
K993546
Medical Analysis Systems, Inc.
Immunology · 42d
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
Cleared Aug 24, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
K992349
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 11, 1999
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
K992550
Bio-Rad
Chemistry · 12d
Cleared Jun 25, 1999
N/T PROTEIN CONTROL LC
K991704
Dade Behring, Inc.
Chemistry · 37d
Cleared May 19, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
K990016
Ortho-Clinical Diagnostics, Inc.
Immunology · 135d
Cleared May 19, 1999
MODIFICATION OF N/T PROTEIN CONTROL SL
K991182
Dade Behring, Inc.
Chemistry · 42d
Cleared Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
K990610
Bio-Rad
Chemistry · 62d