Panels › Clinical Chemistry › Product code JIX · Class 2
Calibrator, Multi-Analyte Mixture
Regulation 862.1150
0510(k)s in 12 months (302 all time)
1recalls in 12 months (73 all time)
60recalls that name a 510(k)
Top companies in JIX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 2006 | K061218 | DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 Dade Behring, Inc. | JIX |
| Apr 24, 2006 | K060940 | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III Ortho-Clinical Diagnostics, Inc. | JIX |
| Jan 13, 2006 | K053153 | RANDOX CALIBRATION SERUM Randox Laboratories, Ltd., GB | JIX |
| Oct 25, 2005 | K051452 | SENTINEL CLIN CHEM CAL Sentinel Ch. Srl, IT | JIX |
| Aug 1, 2005 | K051619 | LIPOPROTEIN FOR MULTIPLE ANALYTES Bayer Healthcare, LLC | JIX |
| Jul 25, 2005 | K051457 | SENTINEL PLASMAPROTEINS CAL 3X Sentinel Ch. Srl, IT | JIX |
| Jan 31, 2005 | K050026 | PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC Roche Diagnostics | JIX |
| Jan 31, 2005 | K043460 | OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 Olympus America, Inc. | JIX |
| Nov 23, 2004 | K041926 | HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 Diagnostic Chemicals , Ltd., CA | JIX |
| Nov 16, 2004 | K042551 | MULTI-CHEM CALIBRATOR A Wako Chemicals USA, Inc. | JIX |
| Nov 8, 2004 | K042550 | MULTI-LIPID CALIBRATOR Wako Chemicals USA, Inc. | JIX |
| Nov 8, 2004 | K042549 | MULTI CHEM CAL B Wako Chemicals USA, Inc. | JIX |
| Oct 4, 2004 | K042243 | MICROALBUMIN MULTI-CALIBRATOR SET Diagnostic Chemicals , Ltd., CA | JIX |
| Sep 28, 2004 | K041905 | HEMOSIL CALIBRATION PLASMA Instrumentation Laboratory CO | JIX |
| Jul 27, 2004 | K041870 | N APOLIPOPROTEIN STANDARD SERUM Dade Behring, Inc. | JIX |
| Apr 2, 2004 | K040264 | CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF Roche Diagnostics Corp. | JIX |
| Mar 24, 2004 | K040245 | CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) Roche Diagnostics Corp. | JIX |
| Mar 12, 2004 | K032936 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR Stanbio Laboratory | JIX |
| Feb 13, 2004 | K033873 | ELECSYS C-PEPTIDE CALSET Roche Diagnostics Corp. | JIX |
| Feb 13, 2004 | K033791 | BAYER SPECIFIC PROTEIN REFERENCE SERUM Bayer Healthcare, LLC | JIX |
| Jan 30, 2004 | K033910 | OLYMPUS URINE CALIBRATOR Cliniqa Corporation | JIX |
| Dec 16, 2003 | K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS Bayer Diagnostics Corp. | JIX |
| Nov 21, 2003 | K032665 | OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 Olympus America, Inc. | JIX |
| Nov 20, 2003 | K033501 | MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) Roche Diagnostics Corp. | JIX |
| Nov 7, 2003 | K033061 | CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE Diamond Diagnostics, Inc. | JIX |
| Aug 18, 2003 | K032287 | MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 Beckman Coulter, Inc. | JIX |
| Aug 8, 2003 | K031608 | RANDOX LIQUID PROTEIN CALIBRATOR Randox Laboratories, Ltd., GB | JIX |
| Aug 6, 2003 | K031683 | TOX AMMONIA CALIBRATOR Bayer Healthcare, LLC | JIX |
| Jul 16, 2003 | K031880 | AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL Roche Diagnostics Corp. | JIX |
| Jun 25, 2003 | K031682 | LIPOPROTEIN CALIBRATOR Bayer Healthcare, LLC | JIX |
| Apr 10, 2003 | K030804 | BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR Bayer Healthcare, LLC | JIX |
| Mar 19, 2003 | K030621 | ATAC CALIBRATOR Elan Diagnostics | JIX |
| Mar 18, 2003 | K024305 | WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 Wiener Laboratories Saic, AR | JIX |
| Jan 31, 2003 | K030169 | SETPOINT CHEMISTRY CALIBRATOR Bayer Healthcare, LLC | JIX |
| Jan 31, 2003 | K023792 | CALIBRATION PACK, MODELS A9100-101S AND A9100-103S Thermo Orion | JIX |
| Jan 21, 2003 | K030074 | LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS Cliniqa Corporation | JIX |
| Dec 10, 2002 | K023876 | VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc. | JIX |
| Nov 15, 2002 | K023268 | PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS Phoenix Diagnostics, Inc. | JIX |
| Oct 24, 2002 | K023158 | RANDOX APOLIPOPROTEIN CALIBRATOR Randox Laboratories, Ltd., GB | JIX |
| Sep 3, 2002 | K022767 | RAICHEM LIPID CALIBRATOR Hemagen Diagnostics, Inc. | JIX |
| Jul 25, 2002 | K022108 | THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 Thermo Dma, Inc. | JIX |
| Feb 15, 2002 | K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION Fisher Diagnostics | JIX |
| Feb 1, 2002 | K020129 | PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE Phoenix Diagnostics, Inc. | JIX |
| Dec 18, 2001 | K013178 | DC-UIBC-CO2-CAL, MODEL SE-153 Diagnostic Chemicals , Ltd., CA | JIX |
| Nov 7, 2001 | K012987 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER Phoenix Diagnostics, Inc. | JIX |
| Oct 9, 2001 | K012509 | PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM Phoenix Diagnostics, Inc. | JIX |
| Sep 28, 2001 | K012470 | MODIFICATION TO N PROTEIN STANDARD SL Dade Behring, Inc. | JIX |
| Sep 24, 2001 | K012250 | RAICHEM MULTI-ANALYTE CALIBRATOR Hemagen Diagnostics, Inc. | JIX |
| Jul 31, 2001 | K011658 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS Rochdiag | JIX |
| Jun 25, 2001 | K011226 | CALIBRATOR FOR AUTOMATED SYSTEMS Roche Diagnostics Corp. | JIX |
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