Atlas FDA

DDR

46 FDA 510(k) clearances · Product code

56 daysmedian time to decision
173 days90th percentile
46clearances measured

FDA profile

Official device name
Myoglobin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5680
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 1 · 2009: 3 · 2011: 5 · 2024: 31
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access Myoglobin (K231832)Beckman Coulter, Inc.2023-09-18
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (K123785)Diazyme Laboratories2013-06-07
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (K122599)Siemens Healthcare Diagnostics, Inc.2012-10-03
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (K083260)Roche Diagnostics2009-10-16
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS (K080481)Beckman Coulter, Inc.2009-02-20
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (K061683)Roche Diagnostics Corp.2006-07-21
ARCHITECT STAT MYO IMMUNOASSAY (K042924)Fisher Diagnostics2005-01-24
QUANTEX MYOGLOBIN (K042982)Instrumentation Laboratory CO2004-12-22
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS (K033300)Ortho-Clinical Diagnostics, Inc.2003-11-05
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 (K021229)Beckman Coulter, Inc.2002-06-28
RAMP MYOGLOBIN ASSAY (K012040)Response Biomedical Corp.2001-12-18
RANDOX MYOGLOBIN (K010700)Randox Laboratories, Ltd.2001-05-08
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 (K000196)Beckman Coulter, Inc.2000-02-18
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR (K992976)Kamiya Biomedical Co.1999-11-01
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 (K991796)Diagnostic Products Corp.1999-06-09
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 (K991277)Diagnostic Products Corp.1999-04-27
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT (K984145)Olympus Diagnostica GmbH1998-12-23
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK (K984065)Dade Behring, Inc.1998-12-14
MYOGLOBIN FLEX REAGENT CARTRIDGE (K984191)Dade Behring, Inc.1998-12-10
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 (K983970)Diagnostic Products Corp.1998-11-25
ABBOTT AXSYM MYOGLOBIN (K983848)Abbott Laboratories1998-11-16
MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (K982679)Spectral Diagnostics, Inc.1998-10-07
ELECSYS MYOGLOBIN STAT ASSAY (K983176)Boehringer Mannheim Corp.1998-09-24
AIA-PACK MYOGLOBIN ASSAY (K981012)Tosoh Medics, Inc.1998-05-28
STRATUS CS MYOGLOBIN (MYO) TESTPAK (K981102)Dade Behring, Inc.1998-04-27
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN (K974325)Chiron Diagnostics Corp.1997-12-08
TINAQUANT MYOGLOBIN ASSAY (K972513)Boehringer Mannheim Corp.1997-07-28
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY (K965213)Dade Intl., Inc.1997-02-10
TARGET MYOGLOBIN TEST (K963680)Texas Immunology, Inc.1997-02-06
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962344)Bayer Corp.1996-08-15
ACCESS MYOGLOBIN REAGENTS (K951634)Bio-Rad Laboratories, Inc.1995-09-27
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN (K952360)Princeton BioMeditech Corp.1995-08-14
LIFESIGN MI MYOGLOBIN (K942052)Princeton Biomedix1995-02-07
MYOGLOBIN ELISA TEST KIT (K923195)Immuno Diagnostic Center, Inc.1992-11-06
STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY (K922125)Baxter Diagnostics, Inc.1992-07-21
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL (K922387)Baxter Diagnostics, Inc.1992-07-15
MYOGLOBIN RIA TEST KIT (K915233)Pro Diagnostics, Inc.1992-03-30
OPUS MYOGLOBIN TEST SYSTEM (K915850)Pb Diagnostic Systems, Inc.1992-03-17
TURBIQUANT MYOGLOBIN (K905202)Behring Diagnostics, Inc.1990-12-13
TURBIQUANT MYOGLOBIN (K903687)Behring Diagnostics, Inc.1990-10-16
MYOGLOBIN RIA TEST KIT (K904038)Immuno Diagnostic Center, Inc.1990-09-24
NA LATEX MYOGLOBIN TEST (K902154)Behring Diagnostics, Inc.1990-06-01
MYOLEX (K863730)Orion Corp.1986-10-15
KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (K780982)Cis Radiopharmaceuticals, Inc.1978-06-22
HEMAGGLUTINATION INHIBITION TEST (K772095)Miles Laboratories, Inc.1978-01-05
ANTISERA TO HUMAN FAB FRAGMENT (K771242)Kent Laboratories, Inc.1977-08-03

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Every clearance here is in the API, with alerts when new ones post.