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JJY

673 FDA 510(k) clearances · Product code

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RecordFirmDate
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 (K012118)Maine Standards Co.2001-08-20
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 (K012119)Maine Standards Co.2001-08-20
MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL (K012243)Hematronix, Inc.2001-08-20
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 (K012120)Maine Standards Co.2001-08-20
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 (K012117)Maine Standards Co.2001-08-20
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 (K011853)Bio-Rad2001-07-17
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 (K011867)Bio-Rad2001-07-12
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 (K011731)Medical Analysis Systems, Inc.2001-07-05
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 (K011579)Bio-Rad2001-06-26
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 (K011548)Medical Analysis Systems, Inc.2001-06-18
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL (K011494)Bio-Rad2001-06-08
HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 (K011169)International Enzymes, Inc.2001-05-18
VIGIL SEROLOGY CONTROL LEVEL C (K010358)Beckman Coulter, Inc.2001-03-05
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK (K010111)Medical Analysis Systems, Inc.2001-02-28
CONFORMANCE CHEMISTRY CONTROL C3 (K003716)Consolidated Technology2000-12-20
SYNCHRON CONTROL (K003488)Beckman Coulter, Inc.2000-11-27
N/T PROTEIN CONTROL SL (K002852)Dade Behring, Inc.2000-11-27
QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 (K001249)Consolidated Technologies of Wisconsin2000-11-02
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 (K002460)Bio-Rad2000-08-31
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 (K002174)Casco-Nerl Diagnostics Corporation (Maine)2000-08-22
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 (K002196)Bio-Rad2000-08-07
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) (K001758)Medical Analysis Systems, Inc.2000-07-05
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 (K001632)Avl Scientific Corp.2000-06-19
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 (K001373)Bio-Rad2000-05-25
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 (K000875)Bio-Rad2000-04-20
QUALITROL LIPID CONTROL, LEVELS 1 AND 2 (K000810)Consolidated Technologies of Wisconsin2000-04-13
ELECSYS CORTISOL TEST SYSTEM (K000270)Roche Diagnostics Corp.2000-03-07
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 (K000116)Consolidated Technologies, Inc.2000-02-15
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION (K981915)The Binding Site, Ltd.1999-12-20
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 (K993631)Seracare Technology1999-12-09
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 (K992939)Seracare Technology1999-12-09
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 (K993546)Medical Analysis Systems, Inc.1999-11-30
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH (K993310)Dade Behring, Inc.1999-11-30
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS (K993023)Beckman Coulter, Inc.1999-11-26
MODIFICATION TO DOCUMENT THYROID CAL.VER (K993014)Casco-Nerl Diagnostics Corporation (Maine)1999-11-26
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K993360)Roche Diagnostics Corp.1999-11-24
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK (K992710)Abbott Laboratories1999-11-24
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K992900)Roche Diagnostics Corp.1999-11-24
QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 (K992770)Seracare Technology1999-11-12
LYPHOCHEK ANEMIA CONTROL, MODEL 500 (K992741)Bio-Rad1999-11-09
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 (K992172)Bio-Rad1999-09-02
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS (K992349)Ortho-Clinical Diagnostics, Inc.1999-08-24
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 (K992550)Bio-Rad1999-08-11
DOCUMENT THYROID CAL*VER (K992034)Casco-Nerl Diagnostics Corporation (Maine)1999-07-23
N/T PROTEIN CONTROL LC (K991704)Dade Behring, Inc.1999-06-25
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (K991447)Spectral Diagnostics, Inc.1999-06-11
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS (K990016)Ortho-Clinical Diagnostics, Inc.1999-05-19
MODIFICATION OF N/T PROTEIN CONTROL SL (K991182)Dade Behring, Inc.1999-05-19
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 (K990610)Bio-Rad1999-04-27
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 (K990888)Bio-Rad1999-04-07
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 (K990424)Bio-Rad1999-03-31
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 (K990317)Bio-Rad1999-03-18
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 (K990394)Bio-Rad1999-03-18
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 (K990391)Bio-Rad1999-03-15
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS (K990531)Ortho-Clinical Diagnostics, Inc.1999-03-12
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 (K990282)Bio-Rad1999-03-09
ELECSYS IGE CALCHECK (K984419)Boehringer Mannheim Corp.1999-02-02
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 (K984594)Bio-Rad1999-02-02
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 (K984477)Bio-Rad1999-01-29
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 (K990161)Bio-Rad1999-01-28
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 (K990150)Bio-Rad1999-01-26
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 (K990149)Bio-Rad1999-01-26
ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 (K990017)Bio-Rad1999-01-25
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 (K984325)Bio-Rad1998-12-17
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 (K983807)Bio-Rad1998-12-16
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 (K984225)Bio-Rad1998-12-14
ELECSYS CALCHECK TROPONIN T (K984372)Boehringer Mannheim Corp.1998-12-14
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 (K984074)Bio-Rad1998-11-20
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY (K983507)Ortho-Clinical Diagnostics, Inc.1998-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K983513)Ortho-Clinical Diagnostics, Inc.1998-11-03
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC (K983492)Boehringer Mannheim Corp.1998-10-09
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983130)Kamiya Biomedical Co.1998-09-29
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS (K983241)Kamiya Biomedical Co.1998-09-29
ELECSYS CALCHECK MYOGLOBIN (K983166)Boehringer Mannheim Corp.1998-09-22
TUMOR MARKER CONTROL (K982473)Diagnostic Products Corp.1998-08-12
IMMULITE PSA CONTROL MODULE, MODEL LPSCM (K982637)Diagnostic Products Corp.1998-08-12
CHEM-CHEX STAT (NEW) (K982290)Streck Laboratories, Inc.1998-07-22
VIGIL PROTEIN CONTROL (K982224)Beckman Coulter, Inc.1998-07-09
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS (K981401)Boehringer Mannheim Corp.1998-05-18
THIRD GENERATION PSA CONTROL MODULE (K981455)Diagnostic Products Corp.1998-05-13
LYPHOCHEK IMMUNOASSAY PLUS CONTROL (K981532)Bio-Rad1998-05-12
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (K981474)Spectral Diagnostics, Inc.1998-05-07
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 (K981339)Consolidated Technologies, Inc.1998-04-21
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 (K980514)Medical Analysis Systems, Inc.1998-03-04
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL (K972904)Casco Standards1998-02-20
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY (K980178)Bionostics, Inc.1998-02-12
VIROTROL III (K974613)Blackhawk Biosystems, Inc.1998-01-27
AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL (K974822)Avl Scientific Corp.1998-01-22
BM PRECIPATH(R) HDL/LDL-C CONTROL (K974826)Boehringer Mannheim Corp.1998-01-22
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE (K974827)Biosite Incorporated1998-01-08
VIGIL LIPID CONTROL (K974452)Beckman Instruments, Inc.1997-12-17
ELECSYS CALCHECK FOLATE (K974384)Boehringer Mannheim Corp.1997-12-08
IMMUSURE (K973894)Quantimetrix Corp.1997-10-29
ABC LINEARITY VERIFIERS (K973790)Sc Calibrators & Controls, LLC1997-10-14
ABC CALIBRATION VERIFIERS (K973791)Sc Calibrators & Controls, LLC1997-10-14
PRECINORM RF, PRECIPATH RF (K973629)Boehringer Mannheim Corp.1997-10-07
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K973517)Johnson & Johnson Clinical Diagnostics, Inc.1997-09-25
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS (K973469)Consolidated Technologies, Inc.1997-09-25
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) (K973030)Johnson & Johnson Clinical Diagnostics, Inc.1997-09-04
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL (K972868)Bionostics, Inc.1997-08-28
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