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
FDA 510(k) Cleared Single (specified) Analyte Controls (assayed And Unassayed) Devices (Product Code JJX)
493 devices
Cleared
Apr 04, 2017
Beta-CrossLaps CalCheck 5
Roche Diagnostics
Chemistry
29d
Cleared
Jan 12, 2017
Elecsys CYFRA 21-1 CalCheck 5
Roche Diagnostics
Immunology
162d
Cleared
Aug 10, 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
Aalto Scientific, Ltd.
Chemistry
33d
Cleared
Jun 30, 2016
LIAISON EBV IgM Serum Control Set
DiaSorin, Inc.
Microbiology
28d
Cleared
Jun 30, 2016
LIAISON CMV IgM Serum Control Set
DiaSorin, Inc.
Microbiology
28d
Cleared
Jul 17, 2015
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material
Siemens Healthcare Diagnostics, Inc.
Chemistry
205d
Cleared
May 01, 2015
Elecsys Progesterone III Cal Check 5
Roche Diagnostics
Chemistry
22d
Cleared
Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
Siemens Healthcare Diagnostics
Chemistry
82d
Cleared
Feb 26, 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
Siemens Healthcare Diagnostics, Inc.
Chemistry
93d
Cleared
Feb 25, 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
Siemens Healthcare Diagnostics, Inc.
Chemistry
65d
Cleared
Jan 27, 2015
ADVIA Centaur IgE Master Curve Material
Siemens Healthcare Diagnostics, Inc.
Immunology
34d
Cleared
Jan 23, 2015
Audit MicroControls Linearity LQ Cystatin-C
Aalto Scientific, Ltd.
Chemistry
37d
Cleared
Jan 23, 2015
IMMULITE 2000 CEA Calibration Verification Material
Siemens Healthcare Diagnostics
Immunology
32d
Cleared
Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
Siemens Healthcare Diagnostics, Inc.
Chemistry
35d
Cleared
Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
Siemens Healthcare Diagnostics, Inc.
Immunology
30d
Cleared
Dec 23, 2014
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material
Siemens Healthcare Diagnostics, Inc.
Immunology
28d
Cleared
Dec 16, 2014
Elecsys Estradiol III Calcheck
Roche Diagnostics
Chemistry
29d
Cleared
Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)
Siemens Healthcare Diagnostics, Inc.
Chemistry
29d
Cleared
Nov 21, 2014
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
Aalto Scientific, Ltd.
Chemistry
31d
Cleared
Oct 30, 2014
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
Siemens Healthcare Diagnostics, Inc.
Chemistry
28d
Cleared
Oct 29, 2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
Siemens Healthcare Diagnostics, Inc.
Chemistry
30d
Cleared
Oct 29, 2014
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
Siemens Healthcare Diagnostics, Inc.
Chemistry
28d
Cleared
Sep 05, 2014
ELECSYS ESTRADIOL III CALCHECK 5
Roche Diagnostics
Chemistry
32d
Cleared
Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
Siemens Healthcare Diagnostics, Inc.
Microbiology
49d