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 |
|---|---|---|---|
| Oct 7, 2010 | K102269 | ELECSYS IGE CALCHECK 5 Roche Diagnostics | JJX |
| Oct 5, 2010 | K101856 | ELECSYS CEA CALCHECK 5 Roche Diagnostics | JJX |
| Oct 5, 2010 | K101365 | ELECSYS CA 19-9 CALCHECK 5 Roche Diagnostics Corp. | JJX |
| Sep 24, 2010 | K102260 | FDI GLUCOSE CONTROL SOLUTIONS Fujirebio Diagnostics,Inc. | JJX |
| Sep 10, 2010 | K102267 | ELECSYS FERRITIN CALCHECK 5 Roche Diagnostics | JJX |
| Aug 31, 2010 | K102044 | ELECSYS DIGOXIN CALCHECK 5 Roche Diagnostics | JJX |
| Jul 29, 2010 | K093724 | FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION Taidoc Technology Corporation, TW | JJX |
| Jun 11, 2010 | K101075 | ELECSYS INSULIN CALCHECK 5 Roche Diagnostics Corp. | JJX |
| May 21, 2010 | K100750 | AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 Aalto Scientific, Ltd. | JJX |
| Apr 27, 2010 | K094031 | ELECSYS FOLATE III CALCHECK 5 Roche Diagnostics | JJX |
| Apr 26, 2010 | K100810 | ELECSYS C-PEPTIDE CALCHECK 5 Roche Diagnostics | JJX |
| Apr 26, 2010 | K092911 | SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER Diazyme Laboratories | JJX |
| Apr 15, 2010 | K093836 | ELECSYS TSH CALCHECK 5 Roche Diagnostics | JJX |
| Apr 14, 2010 | K100747 | CONTREX PLUS LOW CONTROL SOLUTION Apex BioTechnology Corp., TW | JJX |
| Apr 1, 2010 | K100594 | ELECSYS TROPONIN I CALCHECK 5 Roche Diagnostics | JJX |
| Mar 29, 2010 | K093582 | ELECSYS CK-MB CALCHECK 5 Roche Diagnostics | JJX |
| Mar 19, 2010 | K092848 | ELECSYS TROPONIN T CALCHECK 5 Roche Diagnostics Corp. | JJX |
| Mar 4, 2010 | K093700 | ELECSYS HCG STAT CALCHECK 5 Roche Diagnostics Corp. | JJX |
| Dec 16, 2009 | K092169 | ELECSYS PROBNP II CALCHECK 5 Roche Diagnostics | JJX |
| Dec 14, 2009 | K093498 | LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 DiaSorin, Inc. | JJX |
| Dec 3, 2009 | K092749 | MAS AND MINI-TROL PTH CONTROL Microgenics Corporation | JJX |
| Nov 20, 2009 | K092993 | ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL Siemens Healthcare Diagnostics | JJX |
| Nov 16, 2009 | K092168 | ELECSYS HCG+B CALCHECK 5 Roche Diagnostics | JJX |
| Nov 10, 2009 | K092888 | ELECSYS TOXO IGG CALCHECK 5 Roche Diagnostics Corp. | JJX |
| Nov 6, 2009 | K091914 | OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION Bionostics, Inc. | JJX |
| Oct 30, 2009 | K092585 | ELECSYS RUBELLA IGGA CALCHECK 5 Roche Diagnostics | JJX |
| Sep 25, 2009 | K091601 | ELECYS ANTI-CCP CALCHECK Roche Diagnostics Corp. | JJX |
| Sep 9, 2009 | K090104 | LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 DiaSorin, Inc. | JJX |
| Sep 5, 2009 | K092645 | FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 Fujirebio Diagnostics,Inc. | JJX |
| Aug 14, 2009 | K091123 | ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS Siemens Healthcare Diagnostics | JJX |
| Aug 6, 2009 | K091460 | ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 American Biological Technologies, Inc. | JJX |
| May 27, 2009 | K090943 | ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 American Biological Technologies, Inc. | JJX |
| May 5, 2009 | K090311 | ELECSYS RUBELLA IGG CALCHECK Roche Diagnostics | JJX |
| Apr 16, 2009 | K090854 | ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 American Biological Technologies, Inc. | JJX |
| Feb 12, 2009 | K083655 | ELECSYS TOXO IGG CALCHECK Roche Diagnostics | JJX |
| Dec 22, 2008 | K083549 | ABT GLUCOSE CONTROL SOLUTION American Biological Technologies, Inc. | JJX |
| Oct 6, 2008 | K081478 | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS Bionostics, Inc. | JJX |
| Sep 18, 2008 | K082395 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 Bionostics, Inc. | JJX |
| Aug 22, 2008 | K080643 | ELECSYS ANTI-TSHR CALCHECK Roche Diagnostics | JJX |
| Aug 8, 2008 | K081915 | FDTX GLUCOSE CONTROL SOLUTION Fujirebio Diagnostics Texas, Inc. | JJX |
| Aug 8, 2008 | K080273 | AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION Fujirebio Diagnostics Texas, Inc. | JJX |
| Jul 25, 2008 | K081403 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK Bionostics, Inc. | JJX |
| Feb 27, 2008 | K080147 | ELECSYS PROBNP II CALCHECK Roche Diagnostics Corp. | JJX |
| Aug 22, 2007 | K071648 | EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS Canterbury Scientific , Ltd., NZ | JJX |
| Jul 30, 2007 | K071587 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY Inverness Medical Innovations, Inc. | JJX |
| Apr 18, 2007 | K070506 | SMS MULTI GLUCOSE CONTROL, MODEL 2120049 Medical Specialties Supply Co., Inc. | JJX |
| Apr 12, 2007 | K070649 | SMS GLUCOSE CONTROL, MODEL 2120061 Spectrum Medical Supply, Inc. | JJX |
| Apr 2, 2007 | K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT Qualigen, Inc. | JJX |
| Feb 1, 2007 | K063855 | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 Liberty Healthcare Group, Inc. | JJX |
| Oct 13, 2006 | K062972 | PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS Roche Diagnostics Corp. | JJX |
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