JJX · Class I · 21 CFR 862.1660

FDA Product Code JJX: Single (specified) Analyte Controls (assayed And Unassayed)

Leading manufacturers include Boehringer Mannheim Corp., Roche Diagnostics Corp. and Bio-Rad.

493
Total
493
Cleared
62d
Avg days
1976
Since

FDA 510(k) Cleared Single (specified) Analyte Controls (assayed And Unassayed) Devices (Product Code JJX)

493 devices
1–24 of 493
Cleared Apr 04, 2017
Beta-CrossLaps CalCheck 5
K170678
Roche Diagnostics
Chemistry · 29d
Cleared Jan 12, 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173
Roche Diagnostics
Immunology · 162d
Cleared Nov 04, 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
K112603
Beckman Coulter, Inc.
Immunology · 58d
Cleared Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
K101365
Roche Diagnostics Corp.
Immunology · 141d
Cleared Jun 11, 2010
ELECSYS INSULIN CALCHECK 5
K101075
Roche Diagnostics Corp.
Chemistry · 53d
Cleared Mar 19, 2010
ELECSYS TROPONIN T CALCHECK 5
K092848
Roche Diagnostics Corp.
Chemistry · 184d
Cleared Mar 04, 2010
ELECSYS HCG STAT CALCHECK 5
K093700
Roche Diagnostics Corp.
Chemistry · 93d
Cleared Nov 10, 2009
ELECSYS TOXO IGG CALCHECK 5
K092888
Roche Diagnostics Corp.
Microbiology · 50d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601
Roche Diagnostics Corp.
Chemistry · 114d
Cleared Feb 27, 2008
ELECSYS PROBNP II CALCHECK
K080147
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
K043320
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
K042837
Bio-Rad
Chemistry · 19d
Cleared Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
K041687
Abbott Laboratories
Chemistry · 57d
Cleared Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
K040157
Roche Diagnostics Corp.
Chemistry · 33d
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 Nov 29, 2002
ELECSYS PROBNP CALCHECK
K020883
Roche Diagnostics Corp.
Chemistry · 256d
Cleared Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
K020369
Roche Diagnostics Corp.
Immunology · 30d
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130
Dade Behring, Inc.
Chemistry · 29d
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
Cleared Feb 14, 2001
ELECSYS HCG+B CALCHECK
K010237
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jan 12, 2001
CA 125 II CALCHECK
K003967
Roche Diagnostics Corp.
Immunology · 21d

About Product Code JJX - Regulatory Context