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Beckman Coulter, Inc.

270 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
COULTER 4C-EX 300 CELL CONTROL (K100607)Beckman Coulter, Inc.2010-11-18
HDL CHOLESTEROL (HDLX) ASSAY (K100010)Beckman Coulter, Inc.2010-05-14
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (K092505)Beckman Coulter, Inc.2009-12-11
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 (K093458)Beckman Coulter, Inc.2009-12-04
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 (K091846)Beckman Coulter, Inc.2009-10-16
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND (K083867)Beckman Coulter, Inc.2009-08-27
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 (K091742)Beckman Coulter, Inc.2009-08-14
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 (K091153)Beckman Coulter, Inc.2009-07-13
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 (K090588)Beckman Coulter, Inc.2009-05-27
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (K082251)Beckman Coulter, Inc.2009-04-08
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS (K080481)Beckman Coulter, Inc.2009-02-20
COULTER BODY FLUID CONTROL (K082162)Beckman Coulter, Inc.2009-02-03
COULTER 6C CELL CONTROL, MODELS 628027 & A59925 (K081822)Beckman Coulter, Inc.2009-01-21
COULTER LIN-X LINEARITY CONTROL (K081641)Beckman Coulter, Inc.2009-01-16
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K081930)Beckman Coulter, Inc.2008-12-19
FLOWCARE TLG REAGENT (K081526)Beckman Coulter, Inc.2008-08-14
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 (K080634)Beckman Coulter, Inc.2008-08-11
HEMOCCULT ICT (K080812)Beckman Coulter, Inc.2008-06-25
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC (K080869)Beckman Coulter, Inc.2008-05-23
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 (K080166)Beckman Coulter, Inc.2008-03-19
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 (K072612)Beckman Coulter, Inc.2007-10-26
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 (K071681)Beckman Coulter, Inc.2007-10-04
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT (K071002)Beckman Coulter, Inc.2007-06-21
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071280)Beckman Coulter, Inc.2007-06-01
SYNCHRON SYSTEMS CREATININE REAGENT (K071283)Beckman Coulter, Inc.2007-06-01
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071277)Beckman Coulter, Inc.2007-06-01
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (K070626)Beckman Coulter, Inc.2007-05-04
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS (K070144)Beckman Coulter, Inc.2007-02-01
ACCESS EPO ASSAY (K052223)Beckman Coulter, Inc.2006-10-06
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) (K062516)Beckman Coulter, Inc.2006-10-05
COULTER LH 780 HEMATOLOGY ANALYZER (K061616)Beckman Coulter, Inc.2006-10-04
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 (K061190)Beckman Coulter, Inc.2006-09-15
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K061574)Beckman Coulter, Inc.2006-07-21
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 (K061382)Beckman Coulter, Inc.2006-07-06
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 (K061282)Beckman Coulter, Inc.2006-06-02
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 (K061064)Beckman Coulter, Inc.2006-05-17
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT (K060935)Beckman Coulter, Inc.2006-04-28
DRI-STAT ACID PHOSPHATASE REAGENT (K053612)Beckman Coulter, Inc.2006-04-26
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (K060774)Beckman Coulter, Inc.2006-04-21
COULTER 5C CELL CONTROL (K060464)Beckman Coulter, Inc.2006-03-28
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (K060256)Beckman Coulter, Inc.2006-02-27
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (K060130)Beckman Coulter, Inc.2006-02-13
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR (K053090)Beckman Coulter, Inc.2005-12-16
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER (K052905)Beckman Coulter, Inc.2005-11-18
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (K052082)Beckman Coulter, Inc.2005-08-19
ITAG MHC TETRAMER CMV ASSAY (K051122)Beckman Coulter, Inc.2005-08-01
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT (K051307)Beckman Coulter, Inc.2005-06-13
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT (K050119)Beckman Coulter, Inc.2005-05-06
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT (K043556)Beckman Coulter, Inc.2005-03-28
COULTER LH 750 HEMATOLOGY ANALYZER (K050057)Beckman Coulter, Inc.2005-02-10
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K050202)Beckman Coulter, Inc.2005-02-09
FLOWCARE PLG CD4 REAGENT (K043215)Beckman Coulter, Inc.2005-01-19
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT (K042459)Beckman Coulter, Inc.2004-11-17
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS (K042291)Beckman Coulter, Inc.2004-11-12
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER (K042724)Beckman Coulter, Inc.2004-10-29
COULTER A T 5DIFF CAP PIERCE (CP) (K042173)Beckman Coulter, Inc.2004-10-12
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K042651)Beckman Coulter, Inc.2004-10-05
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 (K042195)Beckman Coulter, Inc.2004-09-16
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY (K042281)Beckman Coulter, Inc.2004-09-16
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643)Beckman Coulter, Inc.2004-08-18
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT (K040767)Beckman Coulter, Inc.2004-06-07
ACCESS DHEA-S REAGENT ASSAY (K040181)Beckman Coulter, Inc.2004-03-24
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 (K033036)Beckman Coulter, Inc.2004-02-03
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 (K033038)Beckman Coulter, Inc.2003-12-29
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 (K033603)Beckman Coulter, Inc.2003-12-19
COULTER LH 750 HEMATOLOGY ANALYZER (K032342)Beckman Coulter, Inc.2003-09-26
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K032287)Beckman Coulter, Inc.2003-08-18
COULTER LH 500 HEMATOLOGY ANALYZER (K032000)Beckman Coulter, Inc.2003-08-13
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY (K032162)Beckman Coulter, Inc.2003-08-08
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI (K032035)Beckman Coulter, Inc.2003-08-07
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER (K032013)Beckman Coulter, Inc.2003-07-24
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (K031870)Beckman Coulter, Inc.2003-07-15
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY (K031606)Beckman Coulter, Inc.2003-06-20
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY (K031506)Beckman Coulter, Inc.2003-06-02
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) (K030828)Beckman Coulter, Inc.2003-05-21
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (K031270)Beckman Coulter, Inc.2003-05-06
ACCESS OV MONITOR ASSAY (K031297)Beckman Coulter, Inc.2003-05-02
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (K031269)Beckman Coulter, Inc.2003-05-02
SYNCHRON SYSTEMS OPIATE REAGENT (K031002)Beckman Coulter, Inc.2003-04-29
COULTER LH 750 BODY FLUIDS APPLICATION (K030606)Beckman Coulter, Inc.2003-04-21
COULTER ACT 5DIFF AUTOLOADER (AL) (K030291)Beckman Coulter, Inc.2003-04-17
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A (K030408)Beckman Coulter, Inc.2003-03-04
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR (K024210)Beckman Coulter, Inc.2003-02-24
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764)Beckman Coulter, Inc.2003-01-28
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 (K030012)Beckman Coulter, Inc.2003-01-17
ACCESS TOTAL BHCG (K023480)Beckman Coulter, Inc.2002-12-20
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY (K023597)Beckman Coulter, Inc.2002-12-11
ACCESS TOTAL T4 ASSAY (K023369)Beckman Coulter, Inc.2002-12-09
ACCESS HYPERSENSITIVE HTSH ASSAY (K023093)Beckman Coulter, Inc.2002-11-25
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT (K023048)Beckman Coulter, Inc.2002-11-07
SYNCHRON LX I 725 CLINICAL SYSTEM (K023049)Beckman Coulter, Inc.2002-10-04
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 (K021814)Beckman Coulter, Inc.2002-09-27
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K022161)Beckman Coulter, Inc.2002-07-29
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR (K021572)Beckman Coulter, Inc.2002-07-19
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 (K021229)Beckman Coulter, Inc.2002-06-28
COULTER CELLPREP (K021150)Beckman Coulter, Inc.2002-06-11
MODIFICATION TO VIGIL LIPID CONTROL (K020521)Beckman Coulter, Inc.2002-03-01
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR (K014173)Beckman Coulter, Inc.2002-02-15
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR (K014103)Beckman Coulter, Inc.2002-01-28
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT (K013978)Beckman Coulter, Inc.2002-01-15
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