FDA 510(k) Applications Submitted by YVETTE R LLOYD

FDA 510(k) Number Submission Date Device Name Applicant
K100010 01/04/2010 HDL CHOLESTEROL (HDLX) ASSAY BECKMAN COULTER, INC.
K970146 01/15/1997 ELECSYS CALCHECK TESTOSTERONE BOEHRINGER MANNHEIM CORP.
K970147 01/15/1997 ELECSYS CALCHECK PROLACTIN BOEHRINGER MANNHEIM CORP.
K970148 01/15/1997 ELECSYS CALCHECK ESTRADIOL BOEHRINGER MANNHEIM CORP.
K110251 01/28/2011 SYNCHRON MULTI CALIBRATOR BECKMAN COULTER, INC.
K020610 02/25/2002 LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 BIO-RAD
K970881 03/10/1997 CEDIA DIGOXIN BOEHRINGER MANNHEIM CORP.
K970883 03/10/1997 CEDIA DIGOXIN II BOEHRINGER MANNHEIM CORP.
K970984 03/17/1997 THE ELECSYS CALCHECK PROGESTERONE BOEHRINGER MANNHEIM CORP.
K971060 03/24/1997 PRECINORM TDM CONTROLS BOEHRINGER MANNHEIM CORP.
K971379 04/14/1997 TINAQUANT RHEUMATOID FACTOR ASSAY BOEHRINGER MANNHEIM CORP.
K131189 04/26/2013 UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) BECKMAN COULTER, INC.
K011579 05/22/2001 LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 BIO-RAD
K071753 06/28/2007 MASTERSCREEN PNEUMO & MASTERSCOPE VIASYS HEALTHCARE GMBH
K972433 06/30/1997 CEDIA DIGOXIN CALIBRATORS BOEHRINGER MANNHEIM CORP.
K972513 07/07/1997 TINAQUANT MYOGLOBIN ASSAY BOEHRINGER MANNHEIM CORP.
K062011 07/17/2006 MODIFICATION TO FLOWSCREEN VIASYS HEALTHCARE GMBH
K072061 07/27/2007 MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY VIASYS HEALTHCARE GMBH
K972963 08/11/1997 MODIFIED CEDIA DAU PCP ASSAY BOEHRINGER MANNHEIM CORP.
K072323 08/20/2007 MASTERSCREEN & OXYCON CPX VIASYS HEALTHCARE GMBH
K973358 09/08/1997 MYOGLOBIN CONTROL SET BOEHRINGER MANNHEIM CORP.
K963840 09/24/1996 CEDIA PHENYTOIN II ASSAY BOEHRINGER MANNHEIM CORP.
K964282 10/28/1996 TINA-QUANT FERRITIN ASSAY BOEHRINGER MANNHEIM CORP.
K103373 11/17/2010 SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 BECKMAN COULTER, INC.
K964829 12/02/1996 ELECSYS CALCHECK FSH BOEHRINGER MANNHEIM CORP.
K964830 12/02/1996 ELECSYS CALCHECK LH BOEHRINGER MANNHEIM CORP.
K965109 12/20/1996 ELECSYS ESTRADIOL ASSAY BOEHRINGER MANNHEIM CORP.
K965157 12/23/1996 CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 BOEHRINGER MANNHEIM CORP.
K024217 12/23/2002 LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 BIO-RAD
K024218 12/23/2002 LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 BIO-RAD
K024219 12/23/2002 LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 BIO-RAD
K024220 12/23/2002 LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 BIO-RAD
K024221 12/23/2002 LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 BIO-RAD
K024222 12/23/2002 LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 BIO-RAD
K024223 12/23/2002 LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 BIO-RAD
K024224 12/23/2002 LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 BIO-RAD
K024225 12/23/2002 LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 BIO-RAD
K024226 12/23/2002 LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 BIO-RAD
K024227 12/23/2002 LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 BIO-RAD
K024229 12/23/2002 LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 BIO-RAD
K024230 12/23/2002 LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 BIO-RAD
K024231 12/23/2002 LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 BIO-RAD
K024232 12/23/2002 LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 BIO-RAD
K973112 08/20/1997 ELECSYS DIGOXIN BOEHRINGER MANNHEIM CORP.
K973629 09/24/1997 PRECINORM RF, PRECIPATH RF BOEHRINGER MANNHEIM CORP.
K973702 09/26/1997 ELECSYS VITAMIN B12 ASSAY BOEHRINGER MANNHEIM CORP.


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