DDR · Class II · 21 CFR 866.5680

FDA Product Code DDR: Myoglobin, Antigen, Antiserum, Control

Leading manufacturers include Beckman Coulter, Inc., Behring Diagnostics, Inc. and Dade Behring, Inc..

46
Total
46
Cleared
76d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Myoglobin, Antigen, Antiserum, Control Devices (Product Code DDR)

46 devices
1–24 of 46
Cleared Sep 18, 2023
Access Myoglobin
K231832
Beckman Coulter, Inc.
Chemistry · 88d
Cleared Oct 03, 2012
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Oct 16, 2009
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
K083260
Roche Diagnostics
Chemistry · 345d
Cleared Feb 20, 2009
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
K080481
Beckman Coulter, Inc.
Chemistry · 364d
Cleared Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Dec 22, 2004
QUANTEX MYOGLOBIN
K042982
Instrumentation Laboratory CO
Chemistry · 54d
Cleared Jun 28, 2002
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
K021229
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Feb 18, 2000
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
K000196
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Jun 09, 1999
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796
Diagnostic Products Corp.
Chemistry · 14d
Cleared Apr 27, 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277
Diagnostic Products Corp.
Chemistry · 13d
Cleared Dec 14, 1998
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065
Dade Behring, Inc.
Immunology · 28d
Cleared Dec 10, 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191
Dade Behring, Inc.
Immunology · 17d
Cleared Nov 25, 1998
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
K983970
Diagnostic Products Corp.
Chemistry · 16d
Cleared Nov 16, 1998
ABBOTT AXSYM MYOGLOBIN
K983848
Abbott Laboratories
Chemistry · 17d
Cleared Sep 24, 1998
ELECSYS MYOGLOBIN STAT ASSAY
K983176
Boehringer Mannheim Corp.
Immunology · 14d
Cleared Apr 27, 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102
Dade Behring, Inc.
Immunology · 32d
Cleared Jul 28, 1997
TINAQUANT MYOGLOBIN ASSAY
K972513
Boehringer Mannheim Corp.
Immunology · 21d
Cleared Dec 13, 1990
TURBIQUANT MYOGLOBIN
K905202
Behring Diagnostics, Inc.
Immunology · 23d
Cleared Oct 16, 1990
TURBIQUANT MYOGLOBIN
K903687
Behring Diagnostics, Inc.
Immunology · 62d
Cleared Jun 01, 1990
NA LATEX MYOGLOBIN TEST
K902154
Behring Diagnostics, Inc.
Immunology · 17d
Cleared Jan 05, 1978
HEMAGGLUTINATION INHIBITION TEST
K772095
Miles Laboratories, Inc.
Immunology · 59d

About Product Code DDR - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code DDR since 1977, with 46 receiving FDA clearance (average review time: 76 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.