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
FDA 510(k) Cleared Multi-analyte Controls, All Kinds (assayed) Devices (Product Code JJY)
673 devices
Cleared
Mar 31, 2017
Multichem IA Plus
Techno-Path Manufacturing
Chemistry
203d
Cleared
Mar 10, 2017
Audit MicroControls Linearity FD Tumor Markers II
Aalto Scientific, Ltd.
Immunology
78d
Cleared
Jan 10, 2017
Liquichek Tumor Marker Control-Level 1
Bio-Rad Laboratories
Immunology
74d
Cleared
Jan 28, 2016
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
Radiometer America, Inc.
Chemistry
35d
Cleared
Dec 11, 2015
Liquichek Cardiac Markers Plus Control LT
Bio-Rad Laboratories
Chemistry
308d
Cleared
Apr 30, 2015
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
Maine Standards Company, LLC
Chemistry
198d
Cleared
Mar 13, 2015
Liquichek Maternal Serum II Control
Bio-Rad Laboratories
Chemistry
108d
Cleared
Jan 16, 2015
Audit MicroControls Linearity FD Tumor Markers II
Aalto Scientific, Ltd.
Immunology
30d
Cleared
Dec 08, 2014
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
Randox Laboratories Limited
Chemistry
236d
Cleared
Nov 20, 2014
Audit MicroControls Linearity LQ Special Diabetes
Aalto Scientific, Ltd.
Chemistry
36d
Cleared
Jul 11, 2014
ABX PENTRA MICRO ALB CONTROL L/H
HORIBA ABX SAS
Chemistry
224d
Cleared
Jun 23, 2014
LIQUICHEK TUMOR MARKER CONTROL
Bio-Rad Laboratories
Immunology
59d
Cleared
May 22, 2014
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
Randox Laboratories Limited
Chemistry
79d
Cleared
May 06, 2014
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
Bio-Rad Laboratories
Chemistry
26d
Cleared
Apr 25, 2014
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
Bio-Rad Laboratories
Immunology
29d
Cleared
Apr 24, 2014
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
Bio-Rad Laboratories
Immunology
115d
Cleared
Mar 25, 2014
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
Randox Laboratories Limited
Chemistry
39d
Cleared
Jan 22, 2014
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
Bio-Rad Laboratories
Chemistry
29d
Cleared
Oct 25, 2013
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
Bio-Rad Laboratories
Chemistry
100d
Cleared
Oct 23, 2013
RANDOX CSF CONTROLS LEVELS 2 AND 3
Randox Laboratories, Ltd.
Chemistry
104d
Cleared
Oct 22, 2013
MULTICHEM S PLUS / S PLUS (ASSAYED)
Techno-Path Manufacturing , Ltd.
Chemistry
49d
Cleared
Oct 15, 2013
MULTICHEM U
Techno-Path Manufacturing , Ltd.
Chemistry
109d
Cleared
Oct 07, 2013
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
Helena Laboratories
Immunology
138d
Cleared
Sep 25, 2013
MULTICHEM P
Techno-Path Manufacturing , Ltd.
Immunology
89d