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

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 Oct 26, 2016
Multichem A1c
K162514
Technopath Manufacturing
Chemistry · 48d
Cleared Aug 10, 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874
Aalto Scientific, Ltd.
Chemistry · 33d
Cleared Jun 30, 2016
LIAISON EBV IgM Serum Control Set
K161522
DiaSorin, Inc.
Microbiology · 28d
Cleared Jun 30, 2016
LIAISON CMV IgM Serum Control Set
K161526
DiaSorin, Inc.
Microbiology · 28d
Cleared May 17, 2016
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers
K161082
Immunodiagnostic Systems , Ltd.
Chemistry · 29d
Cleared Apr 21, 2016
Dropper hsCRP High Sensitivity CRP Control
K152117
Quantimetrix Corporation
Chemistry · 266d
Cleared Sep 23, 2015
Contour Next Control Solution
K151742
Bayer Healthcare
Chemistry · 86d
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
K143687
Siemens Healthcare Diagnostics, Inc.
Chemistry · 205d
Cleared May 01, 2015
Elecsys Progesterone III Cal Check 5
K150955
Roche Diagnostics
Chemistry · 22d
Cleared Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
K150132
Siemens Healthcare Diagnostics
Chemistry · 82d
Cleared Mar 30, 2015
IDS-iSYS CTX-I Calibration Verifiers
K143324
Immunodiagnostic Systems , Ltd.
Chemistry · 131d
Cleared Feb 26, 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
K143373
Siemens Healthcare Diagnostics, Inc.
Chemistry · 93d
Cleared Feb 25, 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
K143636
Siemens Healthcare Diagnostics, Inc.
Chemistry · 65d
Cleared Jan 27, 2015
ADVIA Centaur IgE Master Curve Material
K143680
Siemens Healthcare Diagnostics, Inc.
Immunology · 34d
Cleared Jan 23, 2015
Audit MicroControls Linearity LQ Cystatin-C
K143571
Aalto Scientific, Ltd.
Chemistry · 37d
Cleared Jan 23, 2015
IMMULITE 2000 CEA Calibration Verification Material
K143639
Siemens Healthcare Diagnostics
Immunology · 32d
Cleared Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
K143504
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
K143352
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Dec 23, 2014
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material
K143376
Siemens Healthcare Diagnostics, Inc.
Immunology · 28d
Cleared Dec 16, 2014
Elecsys Estradiol III Calcheck
K143284
Roche Diagnostics
Chemistry · 29d
Cleared Dec 16, 2014
AIA-PACK C-Peptide Control Set
K143296
Tosoh Bioscience, Inc.
Chemistry · 29d
Cleared Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)
K143194
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d

About Product Code JJX - Regulatory Context