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
193–216 of 673
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867
Bio-Rad
Chemistry · 28d
Cleared Jul 05, 2001
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
K011731
Medical Analysis Systems, Inc.
Chemistry · 30d
Cleared Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
K011579
Bio-Rad
Immunology · 35d
Cleared Jun 18, 2001
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3
K011548
Medical Analysis Systems, Inc.
Chemistry · 31d
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 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 Jun 19, 2000
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
K001632
Avl Scientific Corp.
Chemistry · 24d
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 Feb 15, 2000
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
K000116
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Dec 20, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
K981915
The Binding Site, Ltd.
Immunology · 567d
Cleared Dec 09, 1999
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
K992939
Seracare Technology
Immunology · 100d
Cleared Dec 09, 1999
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
K993631
Seracare Technology
Immunology · 43d
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
MODIFICATION TO DOCUMENT THYROID CAL.VER
K993014
Casco-Nerl Diagnostics Corporation (Maine)
Immunology · 79d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
K993023
Beckman Coulter, Inc.
Immunology · 78d