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 Jan 26, 2006
OXICOM CONTROL
K053327
Bionostics, Inc.
Chemistry · 56d
Cleared Nov 28, 2005
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
K053059
Roche Diagnostics
Chemistry · 28d
Cleared Nov 18, 2005
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3
K052679
Cliniqa Corporation
Chemistry · 51d
Cleared May 13, 2005
RNA1C CONTROL FOR NYCOCARD HBA1C
K050961
Bionostics, Inc.
Chemistry · 25d
Cleared Feb 25, 2005
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
K050100
Bionostics, Inc.
Chemistry · 38d
Cleared Feb 08, 2005
LIQUICHEK BNP CONTROL
K043584
Bio-Rad Laboratories, Inc.
Chemistry · 42d
Cleared Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
K043320
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 05, 2004
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
K042717
Medical Analysis Systems, Inc.
Chemistry · 36d
Cleared Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
K042837
Bio-Rad
Chemistry · 19d
Cleared Sep 27, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K042303
Ortho-Clinical Diagnostics
Microbiology · 33d
Cleared Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
K041687
Abbott Laboratories
Chemistry · 57d
Cleared Aug 16, 2004
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
K041194
Medical Analysis Systems, Inc.
Chemistry · 102d
Cleared Aug 16, 2004
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
K041898
Cliniqa Corporation
Chemistry · 33d
Cleared May 17, 2004
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
K040918
Wako Chemicals USA, Inc.
Chemistry · 39d
Cleared May 17, 2004
LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS
K040927
Cliniqa Corporation
Chemistry · 38d
Cleared May 07, 2004
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
K041016
Nova Biomedical Corp.
Chemistry · 17d
Cleared Mar 12, 2004
RANDOX LIQUID CRP CONTROLS
K040351
Randox Laboratories, Ltd.
Chemistry · 29d
Cleared Mar 10, 2004
R&D GLU-LINE HEMATOLOGY CONTROL
K034048
R&D Systems, Inc.
Chemistry · 71d
Cleared Mar 05, 2004
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
K040455
Cliniqa Corporation
Chemistry · 11d
Cleared Mar 02, 2004
A1C-CELLULAR
K040025
Streck Laboratories, Inc.
Chemistry · 55d
Cleared Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
K040157
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Jan 02, 2004
NOVA GLUCOSE CONTROL SOLUTIONS
K033433
Nova Biomedical Corp.
Chemistry · 66d
Cleared Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
K032993
Ortho-Clinical Diagnostics, Inc.
Microbiology · 36d
Cleared Oct 31, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
K033127
Ortho-Clinical Diagnostics
Microbiology · 31d