JJX · Class I · 21 CFR 862.1660

FDA Product Code JJX: Single (specified) Analyte Controls (assayed And Unassayed)

Leading manufacturers include Roche Diagnostics, Siemens Healthcare Diagnostics, Inc. and Boehringer Mannheim Corp..

493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
73–96 of 493
Cleared Apr 28, 2011
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
K103683
Siemens Healthcare Diagnostics
Chemistry · 132d
Cleared Apr 20, 2011
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
K110436
Fujirebio Diagnostics,Inc.
Chemistry · 64d
Cleared Feb 10, 2011
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
K103553
Bionostics, Inc.
Chemistry · 69d
Cleared Jan 25, 2011
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
K103450
Fujirebio Diagnostics,Inc.
Chemistry · 62d
Cleared Jan 07, 2011
ELECSYS DHEA-S CALCHECK 5
K103402
Roche Diagnostics
Chemistry · 49d
Cleared Dec 23, 2010
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
K100715
Aalto Scientific, Ltd.
Chemistry · 286d
Cleared Dec 23, 2010
AUDIT MICROCV HS-CRP LINEARITY SET
K101427
Aalto Scientific, Ltd.
Chemistry · 216d
Cleared Dec 06, 2010
PRECICONTROL HBA1C NORM
K103099
Roche Diagnostics
Chemistry · 47d
Cleared Nov 23, 2010
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
K102904
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 18, 2010
ELECSYS PTH CALCHECK 5
K103162
Roche Diagnostics
Chemistry · 22d
Cleared Nov 01, 2010
ELECSYS CA 125 II CALCHECK 5
K102086
Roche Diagnostics
Immunology · 98d
Cleared Oct 07, 2010
ELECSYS IGE CALCHECK 5
K102269
Roche Diagnostics
Immunology · 59d
Cleared Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
K101365
Roche Diagnostics Corp.
Immunology · 141d
Cleared Oct 05, 2010
ELECSYS CEA CALCHECK 5
K101856
Roche Diagnostics
Immunology · 96d
Cleared Sep 24, 2010
FDI GLUCOSE CONTROL SOLUTIONS
K102260
Fujirebio Diagnostics,Inc.
Chemistry · 45d
Cleared Sep 10, 2010
ELECSYS FERRITIN CALCHECK 5
K102267
Roche Diagnostics
Chemistry · 32d
Cleared Aug 31, 2010
ELECSYS DIGOXIN CALCHECK 5
K102044
Roche Diagnostics
Chemistry · 41d
Cleared Jul 29, 2010
FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION
K093724
Taidoc Technology Corporation
Chemistry · 238d
Cleared Jun 11, 2010
ELECSYS INSULIN CALCHECK 5
K101075
Roche Diagnostics Corp.
Chemistry · 53d
Cleared May 21, 2010
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5
K100750
Aalto Scientific, Ltd.
Microbiology · 66d
Cleared Apr 27, 2010
ELECSYS FOLATE III CALCHECK 5
K094031
Roche Diagnostics
Chemistry · 118d
Cleared Apr 26, 2010
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER
K092911
Diazyme Laboratories
Chemistry · 216d
Cleared Apr 26, 2010
ELECSYS C-PEPTIDE CALCHECK 5
K100810
Roche Diagnostics
Chemistry · 35d
Cleared Apr 15, 2010
ELECSYS TSH CALCHECK 5
K093836
Roche Diagnostics
Chemistry · 121d