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
25–48 of 493
Cleared Jul 09, 2014
IMMULITE 2000
K141444
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Jun 24, 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
K133816
Siemens Healthcare Diagnostics, Inc.
Immunology · 190d
Cleared May 01, 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
K140818
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
K140541
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
K140505
Siemens Healthcare Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 27, 2014
ELECSYS PRECICONTROL TS
K140534
Roche Diagnostics
Chemistry · 23d
Cleared Mar 10, 2014
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
K140267
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 05, 2014
IMMULITE 2000 DHEA-SO4
K140258
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Jan 17, 2014
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
K133197
Fujirebio Diagnostics,Inc.
Chemistry · 92d
Cleared Jan 14, 2014
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
K132739
Siemens Healthcare Diagnostics, Inc.
Immunology · 133d
Cleared Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
K133284
Roche Diagnostics
Chemistry · 28d
Cleared Oct 30, 2013
IMMULITE 2000
K133122
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Oct 25, 2013
IMMULITE 2000
K133124
Siemens Healthcare Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 22, 2013
IMMULITE 2000
K133128
Siemens Healthcare Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662
Siemens Healthcare Diagnostics, Inc.
Chemistry · 125d
Cleared Aug 12, 2013
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
K131536
Siemens Healthcare Diagnostics, Inc.
Immunology · 75d
Cleared Jul 26, 2013
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
K131999
Randox Laboratories, Ltd.
Chemistry · 28d
Cleared Jul 18, 2013
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
K131776
Randox Laboratories, Ltd.
Chemistry · 31d
Cleared May 31, 2013
GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
K131136
Bionostics, Inc.
Chemistry · 39d
Cleared Apr 26, 2013
AUDIT MICROCV VITAMIN D LINEARITY SET
K130764
Aalto Scientific, Ltd.
Chemistry · 37d
Cleared Mar 19, 2013
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
K130157
Aalto Scientific, Ltd.
Chemistry · 55d
Cleared Mar 14, 2013
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
K122534
Siemens Healthcare Diagnostics, Inc.
Immunology · 206d
Cleared Feb 14, 2013
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
K123851
Bionostics, Inc.
Chemistry · 62d
Cleared Jan 25, 2013
GLUCOSE METER-CHECK SOLUTION FOR BAYER
K123966
Bionostics, Inc.
Chemistry · 30d