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
49–72 of 673
Cleared Nov 07, 2011
IT/IF CONTROL
K101863
Sebia
Immunology · 493d
Cleared Nov 03, 2011
THERMO SCIENTIFIC MAS OMNI-CORE
K110738
Microgenics Corporation
Chemistry · 231d
Cleared Sep 30, 2011
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904
Randox Laboratories, Ltd.
Chemistry · 183d
Cleared Sep 14, 2011
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
K111996
Elitechgroup
Chemistry · 63d
Cleared Jul 08, 2011
ELECSYS PRECICONTROL VARIA 3
K111506
Roche Diagnostics
Chemistry · 37d
Cleared Jul 05, 2011
VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
K110880
Maine Standards Company, LLC
Chemistry · 97d
Cleared Jun 29, 2011
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
K110616
Microgenics Corp.
Chemistry · 118d
Cleared Jun 28, 2011
VITAL SERUM CONTROLS
K111063
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 71d
Cleared Jun 10, 2011
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K103601
Aalto Scientific, Ltd.
Chemistry · 184d
Cleared May 06, 2011
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
K103364
Diamond Diagnostics, Inc.
Chemistry · 171d
Cleared Jan 25, 2011
MSC LIPID CONTROL
K103271
Maine Standards Co.
Chemistry · 81d
Cleared Jan 14, 2011
AUDIT MICROCV PROTEIN LINEARITY SET
K101216
Aalto Scientific, Ltd.
Chemistry · 259d
Cleared Jan 10, 2011
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
K102617
Aalto Scientific, Ltd.
Chemistry · 122d
Cleared Oct 05, 2010
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
K101809
Fujirebio Diagnostics,Inc.
Immunology · 98d
Cleared Sep 03, 2010
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
K100718
Aalto Scientific, Ltd.
Chemistry · 175d
Cleared Sep 01, 2010
PRECICONTROL CLINCHEM MULTI 1 AND 2
K102016
Roche Diagnostics
Chemistry · 44d
Cleared Aug 31, 2010
AUDIT MICROCV RF/CRP LINEARITY SET
K101226
Aalto Scientific, Ltd.
Immunology · 120d
Cleared Aug 27, 2010
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
K101633
Nova Biomedical Corp.
Chemistry · 78d
Cleared Aug 27, 2010
ELECSYS PRECICONTROL MULTIMARKER
K102157
Roche Diagnostics
Chemistry · 28d
Cleared Mar 19, 2010
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR
K093492
Diamond Diagnostics, Inc.
Chemistry · 129d
Cleared Mar 10, 2010
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
K093384
Diamond Diagnostics, Inc.
Chemistry · 131d
Cleared Nov 13, 2009
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
K093032
Biosite Incorporated
Chemistry · 45d
Cleared Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
K092320
Roche Diagnostics
Chemistry · 91d
Cleared Sep 21, 2009
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
K092051
Microgenics Corp.
Chemistry · 76d