FDA 510(k) Applications for Medical Device Product Code "DDR"
(Myoglobin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983848 ABBOTT LABORATORIES ABBOTT AXSYM MYOGLOBIN 11/16/1998
K922387 BAXTER DIAGNOSTICS, INC. DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL 07/15/1992
K922125 BAXTER DIAGNOSTICS, INC. STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY 07/21/1992
K962344 BAYER CORP. MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) 08/15/1996
K080481 BECKMAN COULTER, INC. ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS 02/20/2009
K000196 BECKMAN COULTER, INC. ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 02/18/2000
K021229 BECKMAN COULTER, INC. MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 06/28/2002
K902154 BEHRING DIAGNOSTICS, INC. NA LATEX MYOGLOBIN TEST 06/01/1990
K903687 BEHRING DIAGNOSTICS, INC. TURBIQUANT MYOGLOBIN 10/16/1990
K905202 BEHRING DIAGNOSTICS, INC. TURBIQUANT MYOGLOBIN 12/13/1990
K951634 BIO-RAD LABORATORIES, INC. ACCESS MYOGLOBIN REAGENTS 09/27/1995
K983176 BOEHRINGER MANNHEIM CORP. ELECSYS MYOGLOBIN STAT ASSAY 09/24/1998
K972513 BOEHRINGER MANNHEIM CORP. TINAQUANT MYOGLOBIN ASSAY 07/28/1997
K974325 CHIRON DIAGNOSTICS CORP. CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN 12/08/1997
K780982 CIS RADIOPHARMACEUTICALS, INC. KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT 06/22/1978
K984191 DADE BEHRING, INC. MYOGLOBIN FLEX REAGENT CARTRIDGE 12/10/1998
K984065 DADE BEHRING, INC. STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK 12/14/1998
K981102 DADE BEHRING, INC. STRATUS CS MYOGLOBIN (MYO) TESTPAK 04/27/1998
K965213 DADE INTL., INC. STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY 02/10/1997
K983970 DIAGNOSTIC PRODUCTS CORP. IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 11/25/1998
K991796 DIAGNOSTIC PRODUCTS CORP. IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 06/09/1999
K991277 DIAGNOSTIC PRODUCTS CORP. MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 04/27/1999
K123785 DIAZYME LABORATORIES DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET 06/07/2013
K042924 FISHER DIAGNOSTICS ARCHITECT STAT MYO IMMUNOASSAY 01/24/2005
K923195 IMMUNO DIAGNOSTIC CENTER, INC. MYOGLOBIN ELISA TEST KIT 11/06/1992
K904038 IMMUNO DIAGNOSTIC CENTER, INC. MYOGLOBIN RIA TEST KIT 09/24/1990
K042982 INSTRUMENTATION LABORATORY CO. QUANTEX MYOGLOBIN 12/22/2004
K992976 KAMIYA BIOMEDICAL CO. K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR 11/01/1999
K771242 KENT LABORATORIES, INC. ANTISERA TO HUMAN FAB FRAGMENT 08/03/1977
K772095 MILES LABORATORIES, INC. HEMAGGLUTINATION INHIBITION TEST 01/05/1978
K984145 OLYMPUS DIAGNOSTICA GMBH OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT 12/23/1998
K863730 ORION CORP. MYOLEX 10/15/1986
K033300 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS 11/05/2003
K915850 PB DIAGNOSTIC SYSTEMS, INC. OPUS MYOGLOBIN TEST SYSTEM 03/17/1992
K952360 PRINCETON BIOMEDITECH CORP. CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN 08/14/1995
K942052 PRINCETON BIOMEDIX LIFESIGN MI MYOGLOBIN 02/07/1995
K915233 PRO DIAGNOSTICS, INC. MYOGLOBIN RIA TEST KIT 03/30/1992
K010700 RANDOX LABORATORIES, LTD. RANDOX MYOGLOBIN 05/08/2001
K012040 RESPONSE BIOMEDICAL CORP. RAMP MYOGLOBIN ASSAY 12/18/2001
K083260 Roche Diagnostics ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN 10/16/2009
K061683 ROCHE DIAGNOSTICS CORP. TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM 07/21/2006
K122599 Siemens Healthcare Diagnostics Inc. ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR 10/03/2012
K982679 SPECTRAL DIAGNOSTICS, INC. MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST 10/07/1998
K963680 TEXAS IMMUNOLOGY, INC. TARGET MYOGLOBIN TEST 02/06/1997
K981012 TOSOH MEDICS, INC. AIA-PACK MYOGLOBIN ASSAY 05/28/1998


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