JJY · Multi-Analyte Controls, All Kinds (Assayed)
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | JJY |
|---|---|
| Device Name | Multi-Analyte Controls, All Kinds (Assayed) |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Classification Rationale
Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Cleared Devices (673)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162530 | Multichem IA Plus | Techno-Path Manufacturing | Mar 31, 2017 | SESE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | Mar 10, 2017 | SESE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Bio-Rad Laboratories | Jan 10, 2017 | SESE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | Radiometer America, Inc. | Jan 28, 2016 | SESE |
| K150300 | Liquichek Cardiac Markers Plus Control LT | Bio-Rad Laboratories | Dec 11, 2015 | SESE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | Apr 30, 2015 | SESE |
| K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories | Mar 13, 2015 | SESE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | Jan 16, 2015 | SESE |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | Randox Laboratories Limited | Dec 8, 2014 | SESE |
| K142978 | Audit MicroControls Linearity LQ Special Diabetes | Aalto Scientific, Ltd. | Nov 20, 2014 | SESE |
| K133676 | ABX PENTRA MICRO ALB CONTROL L/H | HORIBA ABX SAS | Jul 11, 2014 | SESE |
| K141073 | LIQUICHEK TUMOR MARKER CONTROL | Bio-Rad Laboratories | Jun 23, 2014 | SESE |
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL | Randox Laboratories Limited | May 22, 2014 | SESE |
| K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | Bio-Rad Laboratories | May 6, 2014 | SESE |
| K140764 | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK | Bio-Rad Laboratories | Apr 25, 2014 | SESE |
| K134013 | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO | Bio-Rad Laboratories | Apr 24, 2014 | SESE |
| K140393 | RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 | Randox Laboratories Limited | Mar 25, 2014 | SESE |
| K133960 | LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL | Bio-Rad Laboratories | Jan 22, 2014 | SESE |
| K132227 | LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY | Bio-Rad Laboratories | Oct 25, 2013 | SESE |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | Randox Laboratories, Ltd. | Oct 23, 2013 | SESE |
| K132751 | MULTICHEM S PLUS / S PLUS (ASSAYED) | Techno-Path Manufacturing , Ltd. | Oct 22, 2013 | SESE |
| K131993 | MULTICHEM U | Techno-Path Manufacturing , Ltd. | Oct 15, 2013 | SESE |
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | Helena Laboratories | Oct 7, 2013 | SESE |
| K131992 | MULTICHEM P | Techno-Path Manufacturing , Ltd. | Sep 25, 2013 | SESE |
| K132091 | MULTICHEM IA AND IA PLUS | Techno-Path Manufacturing , Ltd. | Sep 20, 2013 | SESE |
| K131595 | EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM | Eurotrol B.V. | Jul 26, 2013 | SESE |
| K130337 | RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 | Randox Laboratories Limited | Jun 19, 2013 | SESE |
| K130963 | LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK | Bio-Rad Laboratories, Inc. | May 6, 2013 | SESE |
| K130762 | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET | Aalto Scientific, Ltd. | Apr 29, 2013 | SESE |
| K124009 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C | Diamond Diagnostics, Inc. | Apr 17, 2013 | SESE |
| K130761 | LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK | Bio-Rad Laboratories | Apr 12, 2013 | SESE |
| K123725 | FASTPACK CONTROL KIT | Qualigen, Inc. | Mar 8, 2013 | SESE |
| K130162 | LIQUID ASSAYED MULTIQUAL PREMIUM | Bio-Rad Laboratories | Mar 1, 2013 | SESE |
| K123775 | LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK | Bio-Rad Laboratories | Jan 31, 2013 | SESE |
| K123663 | LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | Bio-Rad Laboratories | Dec 27, 2012 | SESE |
| K123198 | LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA | Bio-Rad Laboratories | Nov 20, 2012 | SESE |
| K121603 | RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 | Randox Laboratories, Ltd. | Nov 20, 2012 | SESE |
| K122838 | LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK | Bio-Rad Laboratories | Oct 17, 2012 | SESE |
| K113720 | RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 | Randox Laboratories, Ltd. | Sep 20, 2012 | SESE |
| K122291 | THERMO SCIENTIFIC MAS OMNI-CARDIO | Microgenics Corporation | Aug 31, 2012 | SESE |
| K121759 | CONE-TROL LIQUID CHEMISTRY CONTROLS | Cone Bioproducts | Jul 24, 2012 | SESE |
| K121794 | LIQUICHEK URINE CHEMISTRY CONTROL | Bio-Rad, Diagnostics Grp. | Jul 11, 2012 | SESE |
| K121468 | EUROTROL GAS-ISE METABOLITES | Eurotrol B.V. | Jun 22, 2012 | SESE |
| K112742 | AUDIT MICROLQ SPINAL FLUID CONTROL | Aalto Scientific, Ltd. | Jun 15, 2012 | SESE |
| K111964 | AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY | Aalto Scientific, Ltd. | Mar 2, 2012 | SESE |
| K112705 | AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL | Aalto Scientific, Ltd. | Jan 24, 2012 | SESE |
| K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 | Randox Laboratories Limited | Jan 23, 2012 | SESE |
| K112337 | RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL | Randox Laboratories, Ltd. | Dec 1, 2011 | SESE |
| K101863 | IT/IF CONTROL | Sebia | Nov 7, 2011 | SESE |
| K110738 | THERMO SCIENTIFIC MAS OMNI-CORE | Microgenics Corporation | Nov 3, 2011 | SESE |
| K110904 | RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 | Randox Laboratories, Ltd. | Sep 30, 2011 | SESE |
| K111996 | ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 | Elitechgroup | Sep 14, 2011 | SESE |
| K111506 | ELECSYS PRECICONTROL VARIA 3 | Roche Diagnostics | Jul 8, 2011 | SESE |
| K110880 | VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT | Maine Standards Company, LLC | Jul 5, 2011 | SESE |
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO | Microgenics Corp. | Jun 29, 2011 | SESE |
| K111063 | VITAL SERUM CONTROLS | Vital Diagnostics (Manufacturing) Ptyltd | Jun 28, 2011 | SESE |
| K103601 | AUDIT MICROCV IMMUNOASSAY LINEARITY SET | Aalto Scientific, Ltd. | Jun 10, 2011 | SESE |
| K103364 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL | Diamond Diagnostics, Inc. | May 6, 2011 | SESE |
| K103271 | MSC LIPID CONTROL | Maine Standards Co. | Jan 25, 2011 | SESE |
| K101216 | AUDIT MICROCV PROTEIN LINEARITY SET | Aalto Scientific, Ltd. | Jan 14, 2011 | SESE |
| K102617 | AUDIT MICROCV CARDIAC MARKERS LINEARITY SET | Aalto Scientific, Ltd. | Jan 10, 2011 | SESE |
| K102700 | LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS | Alere, San Diego, Dba Biosite INcorporated, Dba IN | Dec 21, 2010 | SESE |
| K101809 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 | Fujirebio Diagnostics,Inc. | Oct 5, 2010 | SESE |
| K100727 | LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK | Bio-Rad, Diagnostics Grp. | Sep 14, 2010 | SESE |
| K100718 | AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 | Aalto Scientific, Ltd. | Sep 3, 2010 | SESE |
| K102016 | PRECICONTROL CLINCHEM MULTI 1 AND 2 | Roche Diagnostics | Sep 1, 2010 | SESE |
| K101226 | AUDIT MICROCV RF/CRP LINEARITY SET | Aalto Scientific, Ltd. | Aug 31, 2010 | SESE |
| K102157 | ELECSYS PRECICONTROL MULTIMARKER | Roche Diagnostics | Aug 27, 2010 | SESE |
| K101633 | NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH | Nova Biomedical Corp. | Aug 27, 2010 | SESE |
| K093492 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR | Diamond Diagnostics, Inc. | Mar 19, 2010 | SESE |
| K093384 | MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) | Diamond Diagnostics, Inc. | Mar 10, 2010 | SESE |
| K093032 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET | Biosite Incorporated | Nov 13, 2009 | SESE |
| K092320 | ELECSYS PRECICONTROL THYROAB | Roche Diagnostics | Nov 3, 2009 | SESE |
| K092051 | THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 | Microgenics Corp. | Sep 21, 2009 | SESE |
| K090541 | ELECSYS PRECICONTROL UNIVERSAL | Roche Diagnostics | Jul 2, 2009 | SESE |
| K091225 | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET | Maine Standards Co. | Jun 25, 2009 | SESE |
| K083554 | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 | Cliniqa Corporation | Apr 21, 2009 | SESE |
| K090475 | VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 | Maine Standards Co. | Apr 16, 2009 | SESE |
| K083891 | VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 | Maine Standards Co. | Mar 23, 2009 | SESE |
| K082714 | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 | Aalto Scientific, Ltd. | Nov 19, 2008 | SESE |
| K082717 | AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 | Aalto Scientific, Ltd. | Oct 30, 2008 | SESE |
| K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | Cliniqa Corporation | Sep 17, 2008 | SESE |
| K082036 | LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK | Bio-Rad Laboratories | Sep 8, 2008 | SESE |
| K082067 | MSC LIPID CONTROL | Maine Standards Co. | Aug 22, 2008 | SESE |
| K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | Cliniqa Corporation | Jun 2, 2008 | SESE |
| K073080 | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 | Bio-Rad Laboratories | Jan 24, 2008 | SESE |
| K072835 | LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK | Bio-Rad, Diagnostics Grp. | Dec 11, 2007 | SESE |
| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | Biosite Incorporated | Dec 7, 2007 | SESE |
| K072246 | VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 | Maine Standards Co. | Sep 14, 2007 | SESE |
| K071980 | DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H | Dade Behring, Inc. | Sep 11, 2007 | SESE |
| K071675 | LIQUICHEK TUMOR MARKER CONTROL | Bio-Rad Laboratories | Jul 3, 2007 | SESE |
| K071433 | SMS GLUCOSE CONTROL, MODEL 2120059 | Specialty Medical Supplies | Jun 28, 2007 | SESE |
| K070741 | CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 | Cliniqa Corporation | May 4, 2007 | SESE |
| K070504 | AMMONIA/ALCOHOL CONTROL SET | Pointe Scientific, Inc., | Apr 11, 2007 | SESE |
| K070200 | TDM CONTROL SET, MODEL CAT# 04521536 | Roche Diagnostics Corp. | Mar 19, 2007 | SESE |
| K070223 | AUDIT MICROCV LIPIDS LINEARITY SET (LOW) | Aalto Scientific, Ltd. | Mar 13, 2007 | SESE |
| K062379 | COBAS INTEGRA CERULOPLASMIN | Roche Diagnostics Corp. | Jan 31, 2007 | SESE |
| K062674 | MISSION TRINITY B | Diamond Diagnostics, Inc. | Dec 1, 2006 | SESE |
| K062593 | CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET | Compass Bioscience | Nov 22, 2006 | SESE |
| K062916 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 | Cliniqa Corporation | Oct 23, 2006 | SESE |
| K062668 | AUDIT MICROCV IMMUNOASSAY LINEARITY SET | Aalto Scientific, Ltd. | Oct 16, 2006 | SESE |
| K061137 | ADVIA IMS CPSA CONTROL | Bayer Healthcare, LLC | Jul 6, 2006 | SESE |
| K061196 | CARDIOIMMUNE XL CARDIAC MARKER CONTROL | Microgenics Corp. | May 30, 2006 | SESE |
| K060850 | NOD CHEMISTRY CONTROL | Bioresource Technology, Inc. | May 30, 2006 | SESE |
| K061182 | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB | Cliniqa Corporation | May 25, 2006 | SESE |
| K060206 | MISSION COMPLETE | Diamond Diagnostics, Inc. | Mar 21, 2006 | SESE |
| K060429 | TDM CONTROL SET | Roche Diagnostics Corp. | Mar 15, 2006 | SESE |
| K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET | Maine Standards Co. | Jan 13, 2006 | SESE |
| K051543 | ELECSYS PRECICONTROL BONE | Roche Diagnostics Corp. | Oct 17, 2005 | SESE |
| K051928 | AUTOCHECK6+ | Radiometer Medical Aps | Oct 12, 2005 | SESE |
| K052056 | DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM | Thermo-Electron Corp. | Sep 23, 2005 | SESE |
| K051687 | ELECSYS PRECICONTROL UNIVERSAL | Roche Diagnostics Corp. | Jul 25, 2005 | SESE |
| K051185 | ELECSYS CA 19-9 CALCHECK | Roche Diagnostics Corp. | Jul 6, 2005 | SESE |
| K051517 | ELECSYS PRECICONTROL ANEMIA | Roche Diagnostics Corp. | Jul 5, 2005 | SESE |
| K050537 | LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS | Bio-Rad | Apr 27, 2005 | SESE |
| K050387 | ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR | Roche Diagnostics Corp. | Apr 25, 2005 | SESE |
| K050504 | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS | Maine Standards Co. | Mar 25, 2005 | SESE |
| K050536 | QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL | Bio-Rad | Mar 24, 2005 | SESE |
| K050125 | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 | More Diagnostics | Mar 18, 2005 | SESE |
| K043208 | LIQUID ASSAYED MULTIQUAL CONTROL | Bio-Rad | Jan 7, 2005 | SESE |
| K042318 | AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET | Aalto Scientific, Ltd. | Dec 9, 2004 | SESE |
| K043108 | LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL | Bio-Rad Laboratories, Inc. | Dec 7, 2004 | SESE |
| K042625 | QUIKREAD CRP CALIBRATOR SET | Orion Diagnostica, OY | Nov 18, 2004 | SESE |
| K042815 | QUEST TUMOR MARKER CONTROL, MODEL 955 | Bio-Rad | Nov 5, 2004 | SESE |
| K041975 | VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 | Maine Standards Co. | Oct 15, 2004 | SESE |
| K042324 | LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 | Bio-Rad | Oct 7, 2004 | SESE |
| K042335 | ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 | Bio-Rad Laboratories, Inc. | Sep 17, 2004 | SESE |
| K042389 | MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA | Roche Diagnostics Corp. | Sep 14, 2004 | SESE |
| K041361 | RANDOX TRI LEVEL CARDIAC CONTROL | Randox Laboratories Limited | Sep 9, 2004 | SESE |
| K041812 | MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) | Roche Diagnostics Corp. | Jul 27, 2004 | SESE |
| K040459 | TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS | Biosite Incorporated | Jul 6, 2004 | SESE |
| K040379 | RANDOX IMMUNOASSAY CONTROL | Randox Laboratories, Ltd. | Jun 16, 2004 | SESE |
| K041227 | MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA | Roche Diagnostics Corp. | May 27, 2004 | SESE |
| K041073 | DOCUMENT SALICYLATE CAL VER | Microgenics Corp. | May 21, 2004 | SESE |
| K040822 | LIQUICHEK TORCH PLUS IGM CONTROL | Bio-Rad Laboratories, Inc. | May 19, 2004 | SESE |
| K040925 | NORMAL AND HYPERGAMMA CONTROL SERUM | Sebia | Apr 28, 2004 | SESE |
| K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | Medical Analysis Systems, Inc. | Apr 28, 2004 | SESE |
| K040352 | NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) | Bioresource Technology, Inc. | Apr 2, 2004 | SESE |
| K040535 | LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS | Cliniqa Corporation | Mar 29, 2004 | SESE |
| K040280 | PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS | Roche Diagnostics Corp. | Mar 11, 2004 | SESE |
| K040277 | LIQUICHEK CARDIAC MARKER CONTROL LT | Bio-Rad Laboratories, Inc. | Mar 10, 2004 | SESE |
| K040273 | LYPHOCHEK ASSAYED CHEMISTRY CONTROL | Bio-Rad Laboratories, Inc. | Mar 4, 2004 | SESE |
| K040091 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | Cliniqa Corporation | Feb 23, 2004 | SESE |
| K033344 | LIGAND PLUS CONTROL LEVEL 1-3 | Consolidated Technology | Jan 16, 2004 | SESE |
| K033937 | ELECSYS PRECICONTROL MULTIANALYTE | Roche Diagnostics Corp. | Jan 7, 2004 | SESE |
| K033379 | BAYER SPECIAL CHEMISTRY CONTROLS | Bayer Diagnostics Corp. | Dec 19, 2003 | SESE |
| K033387 | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 | Bio-Rad | Dec 2, 2003 | SESE |
| K032074 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS | Cliniqa Corporation | Oct 21, 2003 | SESE |
| K033162 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | Cliniqa Corporation | Oct 10, 2003 | SESE |
| K032122 | AUDIT MICROCONTROLS MICROFD BNP CONTROL | Aalto Scientific, Ltd. | Sep 9, 2003 | SESE |
| K032237 | N/T PROTEIN CONTROL | Dade Behring, Inc. | Sep 5, 2003 | SESE |
| K032453 | ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL | Bionostics, Inc. | Aug 28, 2003 | SESE |
| K031921 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS | Cliniqa Corporation | Aug 25, 2003 | SESE |
| K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL | Medical Analysis Systems, Inc. | Aug 19, 2003 | SESE |
| K031577 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS | Cliniqa Corporation | Aug 6, 2003 | SESE |
| K032089 | ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC | Roche Diagnostics Corp. | Jul 30, 2003 | SESE |
| K031575 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS | Cliniqa Corporation | Jul 23, 2003 | SESE |
| K031644 | BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL | Bayer Healthcare, LLC | Jun 25, 2003 | SESE |
| K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 | Hemagen Diagnostics, Inc. | Jun 16, 2003 | SESE |
| K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 | Medical Analysis Systems, Inc. | May 30, 2003 | SESE |
| K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL | Medical Analysis Systems, Inc. | Apr 28, 2003 | SESE |
| K030801 | BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL | Bayer Healthcare, LLC | Apr 9, 2003 | SESE |
| K030705 | CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL | Cliniqa Corporation | Mar 26, 2003 | SESE |
| K030482 | WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 | Wiener Laboratories | Mar 19, 2003 | SESE |
| K030679 | MAS LIPID LEVEL 1 AND 2 | Medical Analysis Systems, Inc. | Mar 14, 2003 | SESE |
| K030566 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS | Cliniqa Corporation | Mar 13, 2003 | SESE |
| K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | Bayer Diagnostics Corp. | Mar 3, 2003 | SESE |
| K030150 | LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS | Cliniqa Corporation | Jan 28, 2003 | SESE |
| K030089 | TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS | Biosite Incorporated | Jan 23, 2003 | SESE |
| K030088 | TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS | Biosite Incorporated | Jan 17, 2003 | SESE |
| K023410 | VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 | Maine Standards Co. | Jan 6, 2003 | SESE |
| K023731 | QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 | Consolidated Technology | Dec 24, 2002 | SESE |
| K023669 | MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA | Medical Analysis Systems, Inc. | Dec 19, 2002 | SESE |
| K023867 | MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 | Medical Analysis Systems, Inc. | Dec 17, 2002 | SESE |
| K023661 | LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS | Cliniqa Corporation | Dec 6, 2002 | SESE |
| K023352 | VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 | Maine Standards Co. | Nov 22, 2002 | SESE |
| K023250 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE | Cliniqa Corporation | Oct 17, 2002 | SESE |
| K022936 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE | Cliniqa Corporation | Oct 2, 2002 | SESE |
| K022885 | LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE | Cliniqa Corporation | Oct 2, 2002 | SESE |
| K022867 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE | Cliniqa Corporation | Oct 2, 2002 | SESE |
| K022851 | PH AND AMINES EXTERNAL CONTROL SET | Quidel Corp. | Sep 27, 2002 | SESE |
| K022991 | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 | Bio-Rad | Sep 17, 2002 | SESE |
| K022591 | RANDOX LIPID CONTROL | Randox Laboratories, Ltd. | Aug 30, 2002 | SESE |
| K022401 | PTS PANELS MULTI-CHEMISTRY CONTROLS | Polymer Technology Systems, Inc. | Aug 21, 2002 | SESE |
| K022041 | LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 | Bio-Rad Laboratories, Inc. | Jul 16, 2002 | SESE |
| K021930 | MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL | Bionostics, Inc. | Jun 25, 2002 | SESE |
| K021381 | MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 | Dade Behring, Inc. | Jun 10, 2002 | SESE |
| K020817 | LIQUICHEK URINE CHEMISTRY CONTROL | Bio-Rad Laboratories, Inc. | Apr 12, 2002 | SESE |
| K020450 | VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 | Maine Standards Co. | Mar 21, 2002 | SESE |
| K020237 | IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 | Consolidated Technology | Mar 19, 2002 | SESE |
| K020521 | MODIFICATION TO VIGIL LIPID CONTROL | Beckman Coulter, Inc. | Mar 1, 2002 | SESE |
| K013995 | MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL | Medical Analysis Systems, Inc. | Dec 21, 2001 | SESE |
| K013734 | MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL | Medical Analysis Systems, Inc. | Dec 7, 2001 | SESE |
| K013332 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE | Cliniqa Corporation | Nov 20, 2001 | SESE |
| K013265 | VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 | Maine Standards Co. | Nov 20, 2001 | SESE |
| K013235 | MODIFICATION TO SYNCHRON CONTROL | Beckman Coulter, Inc. | Oct 16, 2001 | SESE |
| K012468 | MODIFICATION TO N/T PROTEIN CONTROL SL | Dade Behring, Inc. | Sep 4, 2001 | SESE |
| K012855 | LIQUISPX LIQUID LIPID CONTROL | Clinical Controls Division | Aug 30, 2001 | SESE |
| K012513 | LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 | Bio-Rad | Aug 29, 2001 | SESE |
| K012431 | COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 | Bionostics, Inc. | Aug 28, 2001 | SESE |
Top Applicants
- Bio-Rad — 61 clearances
- Medical Analysis Systems, Inc. — 31 clearances
- Cliniqa Corporation — 22 clearances
- Aalto Scientific, Ltd. — 19 clearances
- Bio-Rad Laboratories — 18 clearances
