Panels › Clinical Chemistry › Product code JJX · Class 1
Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation 862.1660
0510(k)s in 12 months (493 all time)
0recalls in 12 months (42 all time)
32recalls that name a 510(k)
Top companies in JJX
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics | 60 | 0 |
| Siemens Healthcare Diagnostics | 34 | 6 |
| Boehringer Mannheim Corp. | 24 | 0 |
| Bionostics, Inc. | 22 | 0 |
| Bio-Rad | 21 | 0 |
| Ortho-Clinical Diagnostics | 13 | 3 |
| Abbott Laboratories | 4 | 9 |
| Beckman Coulter, Inc. | 9 | 4 |
| Casco Standards | 10 | 0 |
| Tosoh Medics, Inc. | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2017 | K170678 | Beta-CrossLaps CalCheck 5 Roche Diagnostics | JJX |
| Jan 12, 2017 | K162173 | Elecsys CYFRA 21-1 CalCheck 5 Roche Diagnostics | JJX |
| Oct 26, 2016 | K162514 | Multichem A1c Technopath Manufacturing, IE | JJX |
| Aug 10, 2016 | K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose Aalto Scientific, Ltd. | JJX |
| Jun 30, 2016 | K161526 | LIAISON CMV IgM Serum Control Set DiaSorin, Inc. | JJX |
| Jun 30, 2016 | K161522 | LIAISON EBV IgM Serum Control Set DiaSorin, Inc. | JJX |
| May 17, 2016 | K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers Immunodiagnostic Systems , Ltd., GB | JJX |
| Apr 21, 2016 | K152117 | Dropper hsCRP High Sensitivity CRP Control Quantimetrix Corporation | JJX |
| Sep 23, 2015 | K151742 | Contour Next Control Solution Bayer Healthcare | JJX |
| Jul 17, 2015 | K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA C Siemens Healthcare Diagnostics, Inc. | JJX |
| May 1, 2015 | K150955 | Elecsys Progesterone III Cal Check 5 Roche Diagnostics | JJX |
| Apr 13, 2015 | K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module Siemens Healthcare Diagnostics | JJX |
| Mar 30, 2015 | K143324 | IDS-iSYS CTX-I Calibration Verifiers Immunodiagnostic Systems , Ltd., GB | JJX |
| Feb 26, 2015 | K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibratio Siemens Healthcare Diagnostics, Inc. | JJX |
| Feb 25, 2015 | K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Mater Siemens Healthcare Diagnostics, Inc. | JJX |
| Jan 27, 2015 | K143680 | ADVIA Centaur IgE Master Curve Material Siemens Healthcare Diagnostics, Inc. | JJX |
| Jan 23, 2015 | K143639 | IMMULITE 2000 CEA Calibration Verification Material Siemens Healthcare Diagnostics | JJX |
| Jan 23, 2015 | K143571 | Audit MicroControls Linearity LQ Cystatin-C Aalto Scientific, Ltd. | JJX |
| Jan 14, 2015 | K143504 | IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material Siemens Healthcare Diagnostics, Inc. | JJX |
| Dec 24, 2014 | K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material Siemens Healthcare Diagnostics, Inc. | JJX |
| Dec 23, 2014 | K143376 | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material Siemens Healthcare Diagnostics, Inc. | JJX |
| Dec 16, 2014 | K143296 | AIA-PACK C-Peptide Control Set Tosoh Bioscience, Inc. | JJX |
| Dec 16, 2014 | K143284 | Elecsys Estradiol III Calcheck Roche Diagnostics | JJX |
| Dec 5, 2014 | K143194 | ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) Siemens Healthcare Diagnostics, Inc. | JJX |
| Nov 21, 2014 | K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity Aalto Scientific, Ltd. | JJX |
| Oct 30, 2014 | K142878 | IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Ver Siemens Healthcare Diagnostics, Inc. | JJX |
| Oct 29, 2014 | K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) Siemens Healthcare Diagnostics, Inc. | JJX |
| Oct 29, 2014 | K142811 | IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), Siemens Healthcare Diagnostics, Inc. | JJX |
| Sep 5, 2014 | K142127 | ELECSYS ESTRADIOL III CALCHECK 5 Roche Diagnostics | JJX |
| Aug 19, 2014 | K141772 | IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. | JJX |
| Jul 9, 2014 | K141444 | IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL Siemens Healthcare Diagnostics, Inc. | JJX |
| Jun 24, 2014 | K133816 | IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. | JJX |
| May 1, 2014 | K140818 | IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C Siemens Healthcare Diagnostics, Inc. | JJX |
| Apr 1, 2014 | K140541 | IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C Siemens Healthcare Diagnostics, Inc. | JJX |
| Mar 31, 2014 | K140505 | ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL Siemens Healthcare Diagnostics, Inc. | JJX |
| Mar 27, 2014 | K140534 | ELECSYS PRECICONTROL TS Roche Diagnostics | JJX |
| Mar 10, 2014 | K140267 | ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) Siemens Healthcare Diagnostics, Inc. | JJX |
| Mar 5, 2014 | K140258 | IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. | JJX |
| Feb 5, 2014 | K133550 | VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT Maine Standards Company, LLC | JJX |
| Jan 17, 2014 | K133197 | FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE Fujirebio Diagnostics,Inc. | JJX |
| Jan 14, 2014 | K132739 | IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. | JJX |
| Nov 22, 2013 | K133284 | ELECSYS CK-MB CALCHECK 5 Roche Diagnostics | JJX |
| Oct 30, 2013 | K133122 | IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) Siemens Healthcare Diagnostics, Inc. | JJX |
| Oct 25, 2013 | K133124 | IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA Siemens Healthcare Diagnostics, Inc. | JJX |
| Oct 24, 2013 | K133003 | RIGHTEST CONTROL SOLUTION Bionime Corporation | JJX |
| Oct 22, 2013 | K133128 | IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION Siemens Healthcare Diagnostics, Inc. | JJX |
| Oct 10, 2013 | K131662 | IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. | JJX |
| Sep 20, 2013 | K132391 | IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL Siemens Helathcare Diagnostics, Inc. | JJX |
| Aug 12, 2013 | K131536 | IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. | JJX |
| Jul 26, 2013 | K131999 | HBA1C CONTROL, LEVEL 1 AND LEVEL 2 Randox Laboratories, Ltd., GB | JJX |
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