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319 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
MRSASelect II (K171061)Bio-Rad2017-12-28
VRESELECT CULTURE MEDIUM (K122187)Bio-Rad2012-11-06
VRESELECT CULTURE MEDIUM (K103684)Bio-Rad2011-10-21
PLATELIA ASPERGILLUS EIA MODEL 62793 (K093678)Bio-Rad2011-01-13
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (K100589)Bio-Rad2010-10-29
PLATELIA LYME IGM (K081362)Bio-Rad2008-06-26
MRSASELECT - EXTENDED INCUBATION (K081212)Bio-Rad2008-06-13
PLATELIA LYME IGG ASSAY (K080012)Bio-Rad2008-05-08
MRSASELECT (K070361)Bio-Rad2007-09-13
PLATELIA ASPERGILLUS EIA, MODEL 62793 (K060641)Bio-Rad2006-06-02
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (K052838)Bio-Rad2005-11-09
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK (K052053)Bio-Rad2005-08-09
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS (K050537)Bio-Rad2005-04-27
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL (K050536)Bio-Rad2005-03-24
LIQUID ASSAYED MULTIQUAL CONTROL (K043208)Bio-Rad2005-01-07
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) (K042865)Bio-Rad2004-11-24
QUEST TUMOR MARKER CONTROL, MODEL 955 (K042815)Bio-Rad2004-11-05
LIQUICHEK RETICULOCYTE CONTROL (A) (K042836)Bio-Rad2004-11-05
LIQUICHEK ELEVATED CRP CONTROL (K042837)Bio-Rad2004-11-02
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 (K042324)Bio-Rad2004-10-07
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL (K041561)Bio-Rad2004-07-06
LIQUICHEK HEMATOLOGY CONTROL (A) (K041457)Bio-Rad2004-06-28
LYPHOCHEK HEMOSTASIS CONTROL (K040275)Bio-Rad2004-02-27
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 (K033366)Bio-Rad2003-12-12
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) (K033404)Bio-Rad2003-12-12
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K033387)Bio-Rad2003-12-02
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 (K032611)Bio-Rad2003-09-17
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 (K032017)Bio-Rad2003-08-08
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS (K031231)Bio-Rad2003-06-18
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (K023857)Bio-Rad2003-05-16
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 (K030182)Bio-Rad2003-02-24
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (K024218)Bio-Rad2003-01-17
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 (K024220)Bio-Rad2003-01-17
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (K024232)Bio-Rad2003-01-17
LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 (K024222)Bio-Rad2003-01-15
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 (K024217)Bio-Rad2003-01-15
LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 (K024224)Bio-Rad2003-01-15
LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 (K024227)Bio-Rad2003-01-15
LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 (K024225)Bio-Rad2003-01-15
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 (K024229)Bio-Rad2003-01-15
LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 (K024230)Bio-Rad2003-01-15
LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 (K024221)Bio-Rad2003-01-15
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (K024219)Bio-Rad2003-01-15
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 (K024231)Bio-Rad2003-01-13
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 (K024223)Bio-Rad2003-01-13
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 (K024226)Bio-Rad2003-01-10
BIO-RAD PLATELIA TOXO IGG TMB (K013839)Bio-Rad2002-09-30
BIO-RAD PLATELIA TOXO IGM TMB (K013837)Bio-Rad2002-09-30
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 (K022991)Bio-Rad2002-09-17
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 (K022707)Bio-Rad2002-08-22
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 (K022529)Bio-Rad2002-08-15
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 (K022525)Bio-Rad2002-08-15
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 (K021414)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 (K021411)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 (K021384)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 (K021415)Bio-Rad2002-05-29
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (K021498)Bio-Rad2002-05-24
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 (K020610)Bio-Rad2002-04-22
LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (K020878)Bio-Rad2002-04-15
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 (K012722)Bio-Rad2001-09-18
LIQUICHEK TDM CONTROL (K012741)Bio-Rad2001-09-12
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (K012656)Bio-Rad2001-09-06
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 (K012513)Bio-Rad2001-08-29
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
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 (K011579)Bio-Rad2001-06-26
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL (K011494)Bio-Rad2001-06-08
VARIANT II TOTAL GHB (K003280)Bio-Rad2000-12-19
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (K003242)Bio-Rad2000-11-30
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (K003239)Bio-Rad2000-11-30
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (K003030)Bio-Rad2000-11-29
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (K002865)Bio-Rad2000-09-25
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (K002866)Bio-Rad2000-09-25
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 (K002460)Bio-Rad2000-08-31
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) (K002536)Bio-Rad2000-08-30
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 (K002535)Bio-Rad2000-08-30
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 (K002120)Bio-Rad2000-08-21
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 (K002196)Bio-Rad2000-08-07
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
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 (K000874)Bio-Rad2000-04-18
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 (K992781)Bio-Rad2000-04-05
BIO-RAD HOMOCYSTEINE BY HPLC (K993107)Bio-Rad1999-12-21
LYPHOCHEK ANEMIA CONTROL, MODEL 500 (K992741)Bio-Rad1999-11-09
BIO-RAD CODA NEONATAL GALT ASSAY (K993536)Bio-Rad1999-11-04
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 (K992172)Bio-Rad1999-09-02
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 (K992550)Bio-Rad1999-08-11
VARIANT II B-THALASSEMIA (K991127)Bio-Rad1999-06-10
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 (K990610)Bio-Rad1999-04-27
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 (K990858)Bio-Rad1999-04-21
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 (K990928)Bio-Rad1999-04-16
MICROPLATE NEONATAL GALT ASSAY (K990827)Bio-Rad1999-04-09
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 (K990587)Bio-Rad1999-04-07
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
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 (K990608)Bio-Rad1999-03-30
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 (K990393)Bio-Rad1999-03-22
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
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