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
49–72 of 493
Cleared Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
K123612
Fujirebio Diagnostics,Inc.
Chemistry · 55d
Cleared Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
K123798
Bio-Rad Laboratories
Chemistry · 30d
Cleared Dec 05, 2012
ELECSYS CA 15-3 II CALCHECK 5
K122242
Roche Diagnostics
Immunology · 131d
Cleared Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
K121895
Roche Diagnostics
Microbiology · 56d
Cleared Jul 11, 2012
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
K121746
Randox Laboratories, Ltd.
Chemistry · 27d
Cleared Jun 20, 2012
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
K121588
Randox Laboratories, Ltd.
Chemistry · 20d
Cleared May 18, 2012
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
K121237
Cliniqa Corporation
Chemistry · 24d
Cleared May 10, 2012
COMPLETE D 25-OH VITAMIN D CONTROL
K113177
Quantimetrix Corp.
Chemistry · 195d
Cleared May 10, 2012
ELECSYS LH CALCHECK 5
K121279
Roche Diagnostics
Chemistry · 10d
Cleared May 09, 2012
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
K121084
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d
Cleared Apr 09, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
K112653
ACON Laboratories, Inc.
Chemistry · 210d
Cleared Jan 31, 2012
AUDIT MICROCV T-UPTAKE LINEARITY
K112143
Aalto Scientific, Ltd.
Chemistry · 189d
Cleared Jan 30, 2012
GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
K113764
Bionostics, Inc.
Chemistry · 40d
Cleared Dec 23, 2011
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
K112352
Bionostics, Inc.
Chemistry · 129d
Cleared Nov 04, 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
K112603
Beckman Coulter, Inc.
Immunology · 58d
Cleared Sep 21, 2011
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
K110061
Siemens Healthcare Diagnostics
Chemistry · 254d
Cleared Sep 19, 2011
GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
K112356
Bionostics, Inc.
Chemistry · 34d
Cleared Sep 14, 2011
ELECSYS MYOGLOBIN CALCHECK 5
K112113
Roche Diagnostics
Chemistry · 51d
Cleared Aug 25, 2011
ELECSYS N-MID OSTEOCALCIN CALCHECK 5
K112104
Roche Diagnostics
Chemistry · 34d
Cleared Jul 21, 2011
ELECSYS T3 CALCHECK 5
K111552
Roche Diagnostics
Chemistry · 48d
Cleared Jun 09, 2011
ELECSYS SHBG CALCHECK 5
K111349
Roche Diagnostics
Chemistry · 27d
Cleared May 27, 2011
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
K110641
Fujirebio Diagnostics,Inc.
Chemistry · 84d
Cleared May 12, 2011
DROPPER A1C DIABETES CONTROL
K103744
Quantimetrix Corp.
Chemistry · 140d
Cleared May 12, 2011
ELECSYS PROLACTIN II CALCHECK 5
K110613
Roche Diagnostics
Chemistry · 70d