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
145–168 of 493
Cleared Oct 20, 2003
GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM
K032819
Bionostics, Inc.
Chemistry · 40d
Cleared Aug 20, 2003
ELECYS SHBG CALCHECK
K031698
Roche Diagnostics Corp.
Chemistry · 79d
Cleared Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
K031990
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Jul 16, 2003
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
K031890
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Mar 17, 2003
SAS RSV CONTROL KIT
K030628
Sa Scientific, Inc.
Chemistry · 18d
Cleared Feb 11, 2003
WAKO NEFA LINEARITY SET
K030065
Wako Chemicals USA, Inc.
Toxicology · 35d
Cleared Nov 29, 2002
ELECSYS PROBNP CALCHECK
K020883
Roche Diagnostics Corp.
Chemistry · 256d
Cleared Nov 13, 2002
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
K022769
Bionostics, Inc.
Chemistry · 84d
Cleared Oct 31, 2002
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
K023307
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Sep 17, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
K022758
Cliniqa Corporation
Chemistry · 28d
Cleared Aug 27, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K022491
Cliniqa Corporation
Chemistry · 29d
Cleared Aug 01, 2002
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
K022232
Cliniqa Corporation
Chemistry · 22d
Cleared Jul 12, 2002
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
K021624
Bionostics, Inc.
Chemistry · 57d
Cleared Jul 12, 2002
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
K021697
Bionostics, Inc.
Chemistry · 51d
Cleared Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
K020369
Roche Diagnostics Corp.
Immunology · 30d
Cleared Dec 21, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
K013900
Ortho-Clinical Diagnostics
Toxicology · 28d
Cleared Oct 24, 2001
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147
Bionostics, Inc.
Chemistry · 34d
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130
Dade Behring, Inc.
Chemistry · 29d
Cleared Aug 29, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
K012561
Ortho-Clinical Diagnostics
Microbiology · 21d
Cleared Aug 27, 2001
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
K012430
Bionostics, Inc.
Chemistry · 27d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250
Ortho-Clinical Diagnostics, Inc.
Microbiology · 50d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
K011463
Ortho-Clinical Diagnostics
Chemistry · 30d
Cleared Apr 11, 2001
VIGIL DNASE B CONTROL
K010693
Beckman Coulter, Inc.
Immunology · 34d
Cleared Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428
Beckman Coulter, Inc.
Chemistry · 28d