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 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 Jan 27, 2012
VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K113524
Maine Standards Co.
Chemistry · 59d
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 Oct 18, 2011
ELECSYS T4 CALCHECK 5
K112528
Roche Diagnostics Corporation
Chemistry · 48d
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 Sep 06, 2011
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
K111650
Immunodiagnostic Systems , Ltd.
Chemistry · 85d
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
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 Mar 16, 2011
IDS-ISYS IFG-I CONTROL SET
K110412
Immunodiagnostic Systems , Ltd.
Chemistry · 30d
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