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
121–144 of 493
Cleared Dec 03, 2009
MAS AND MINI-TROL PTH CONTROL
K092749
Microgenics Corporation
Immunology · 86d
Cleared Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
K092993
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 16, 2009
ELECSYS HCG+B CALCHECK 5
K092168
Roche Diagnostics
Chemistry · 118d
Cleared Nov 10, 2009
ELECSYS TOXO IGG CALCHECK 5
K092888
Roche Diagnostics Corp.
Microbiology · 50d
Cleared Nov 06, 2009
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
K091914
Bionostics, Inc.
Chemistry · 129d
Cleared Oct 30, 2009
ELECSYS RUBELLA IGGA CALCHECK 5
K092585
Roche Diagnostics
Microbiology · 67d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601
Roche Diagnostics Corp.
Chemistry · 114d
Cleared Sep 09, 2009
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
K090104
DiaSorin, Inc.
Chemistry · 237d
Cleared Sep 05, 2009
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
K092645
Fujirebio Diagnostics,Inc.
Chemistry · 9d
Cleared Aug 14, 2009
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
K091123
Siemens Healthcare Diagnostics
Chemistry · 119d
Cleared Aug 06, 2009
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
K091460
American Biological Technologies, Inc.
Chemistry · 80d
Cleared May 27, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
K090943
American Biological Technologies, Inc.
Chemistry · 54d
Cleared May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
K090311
Roche Diagnostics
Microbiology · 88d
Cleared Apr 16, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
K090854
American Biological Technologies, Inc.
Chemistry · 17d
Cleared Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
K083655
Roche Diagnostics
Microbiology · 64d
Cleared Dec 22, 2008
ABT GLUCOSE CONTROL SOLUTION
K083549
American Biological Technologies, Inc.
Chemistry · 21d
Cleared Oct 06, 2008
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
K081478
Bionostics, Inc.
Chemistry · 132d
Cleared Sep 18, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
K082395
Bionostics, Inc.
Chemistry · 30d
Cleared Aug 22, 2008
ELECSYS ANTI-TSHR CALCHECK
K080643
Roche Diagnostics
Chemistry · 169d
Cleared Aug 08, 2008
AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION
K080273
Fujirebio Diagnostics Texas, Inc.
Chemistry · 189d
Cleared Aug 08, 2008
FDTX GLUCOSE CONTROL SOLUTION
K081915
Fujirebio Diagnostics Texas, Inc.
Chemistry · 36d
Cleared Jul 25, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
K081403
Bionostics, Inc.
Chemistry · 67d
Cleared Feb 27, 2008
ELECSYS PROBNP II CALCHECK
K080147
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Aug 22, 2007
EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
K071648
Canterbury Scientific , Ltd.
Chemistry · 65d