Myoglobin, Antigen, Antiserum, Control

FDA product code DDR · 46 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5680
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-08-03 – 2023-09-18

DDR 2023-09-18

Access Myoglobin

Applicant Beckman Coulter, Inc.

K number K231832

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DDR 2013-06-07

DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET

Applicant Diazyme Laboratories

K number K123785

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DDR 2012-10-03

ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR

Applicant Siemens Healthcare Diagnostics, Inc.

K number K122599

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DDR 2009-10-16

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

Applicant Roche Diagnostics

K number K083260

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DDR 2009-02-20

ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS

Applicant Beckman Coulter, Inc.

K number K080481

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DDR 2006-07-21

TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K061683

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DDR 2005-01-24

ARCHITECT STAT MYO IMMUNOASSAY

Applicant Fisher Diagnostics

K number K042924

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DDR 2004-12-22

QUANTEX MYOGLOBIN

Applicant Instrumentation Laboratory CO

K number K042982

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DDR 2003-11-05

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K033300

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DDR 2002-06-28

MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244

Applicant Beckman Coulter, Inc.

K number K021229

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DDR 2001-12-18

RAMP MYOGLOBIN ASSAY

Applicant Response Biomedical Corp.

K number K012040

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DDR 2001-05-08

RANDOX MYOGLOBIN

Applicant Randox Laboratories, Ltd.

K number K010700

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DDR 2000-02-18

ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316

Applicant Beckman Coulter, Inc.

K number K000196

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DDR 1999-11-01

K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR

Applicant Kamiya Biomedical Co.

K number K992976

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DDR 1999-06-09

IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5

Applicant Diagnostic Products Corp.

K number K991796

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DDR 1999-04-27

MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5

Applicant Diagnostic Products Corp.

K number K991277

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DDR 1998-12-23

OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT

Applicant Olympus Diagnostica GmbH

K number K984145

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DDR 1998-12-14

STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK

Applicant Dade Behring, Inc.

K number K984065

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DDR 1998-12-10

MYOGLOBIN FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K984191

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DDR 1998-11-25

IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5

Applicant Diagnostic Products Corp.

K number K983970

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DDR 1998-11-16

ABBOTT AXSYM MYOGLOBIN

Applicant Abbott Laboratories

K number K983848

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DDR 1998-10-07

MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST

Applicant Spectral Diagnostics, Inc.

K number K982679

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DDR 1998-09-24

ELECSYS MYOGLOBIN STAT ASSAY

Applicant Boehringer Mannheim Corp.

K number K983176

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DDR 1998-05-28

AIA-PACK MYOGLOBIN ASSAY

Applicant Tosoh Medics, Inc.

K number K981012

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DDR 1998-04-27

STRATUS CS MYOGLOBIN (MYO) TESTPAK

Applicant Dade Behring, Inc.

K number K981102

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DDR 1997-12-08

CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN

Applicant Chiron Diagnostics Corp.

K number K974325

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DDR 1997-07-28

TINAQUANT MYOGLOBIN ASSAY

Applicant Boehringer Mannheim Corp.

K number K972513

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DDR 1997-02-10

STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY

Applicant Dade Intl., Inc.

K number K965213

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DDR 1997-02-06

TARGET MYOGLOBIN TEST

Applicant Texas Immunology, Inc.

K number K963680

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DDR 1996-08-15

MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

Applicant Bayer Corp.

K number K962344

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DDR 1995-09-27

ACCESS MYOGLOBIN REAGENTS

Applicant Bio-Rad Laboratories, Inc.

K number K951634

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DDR 1995-08-14

CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN

Applicant Princeton BioMeditech Corp.

K number K952360

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DDR 1995-02-07

LIFESIGN MI MYOGLOBIN

Applicant Princeton Biomedix

K number K942052

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DDR 1992-11-06

MYOGLOBIN ELISA TEST KIT

Applicant Immuno Diagnostic Center, Inc.

K number K923195

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DDR 1992-07-21

STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant Baxter Diagnostics, Inc.

K number K922125

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DDR 1992-07-15

DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL

Applicant Baxter Diagnostics, Inc.

K number K922387

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DDR 1992-03-30

MYOGLOBIN RIA TEST KIT

Applicant Pro Diagnostics, Inc.

K number K915233

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DDR 1992-03-17

OPUS MYOGLOBIN TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K915850

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DDR 1990-12-13

TURBIQUANT MYOGLOBIN

Applicant Behring Diagnostics, Inc.

K number K905202

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DDR 1990-10-16

TURBIQUANT MYOGLOBIN

Applicant Behring Diagnostics, Inc.

K number K903687

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DDR 1990-09-24

MYOGLOBIN RIA TEST KIT

Applicant Immuno Diagnostic Center, Inc.

K number K904038

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DDR 1990-06-01

NA LATEX MYOGLOBIN TEST

Applicant Behring Diagnostics, Inc.

K number K902154

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DDR 1986-10-15

MYOLEX

Applicant Orion Corp.

K number K863730

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DDR 1978-06-22

KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT

Applicant Cis Radiopharmaceuticals, Inc.

K number K780982

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DDR 1978-01-05

HEMAGGLUTINATION INHIBITION TEST

Applicant Miles Laboratories, Inc.

K number K772095

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DDR 1977-08-03

ANTISERA TO HUMAN FAB FRAGMENT

Applicant Kent Laboratories, Inc.

K number K771242

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