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
46 devices
25–46 of 46
Cleared Dec 08, 1997
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
K974325
Chiron Diagnostics Corp.
Chemistry · 20d
Cleared Jul 28, 1997
TINAQUANT MYOGLOBIN ASSAY
K972513
Boehringer Mannheim Corp.
Immunology · 21d
Cleared Feb 10, 1997
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
K965213
Dade Intl., Inc.
Immunology · 42d
Cleared Feb 06, 1997
TARGET MYOGLOBIN TEST
K963680
Texas Immunology, Inc.
Immunology · 143d
Cleared Aug 15, 1996
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K962344
Bayer Corp.
Immunology · 58d
Cleared Sep 27, 1995
ACCESS MYOGLOBIN REAGENTS
K951634
Bio-Rad Laboratories, Inc.
Chemistry · 173d
Cleared Aug 14, 1995
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K952360
Princeton BioMeditech Corp.
Immunology · 103d
Cleared Jul 21, 1992
STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY
K922125
Baxter Diagnostics, Inc.
Immunology · 76d
Cleared Jul 15, 1992
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL
K922387
Baxter Diagnostics, Inc.
Immunology · 56d
Cleared Mar 17, 1992
OPUS MYOGLOBIN TEST SYSTEM
K915850
Pb Diagnostic Systems, Inc.
Immunology · 82d
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 Oct 15, 1986
MYOLEX
K863730
Orion Corp.
Immunology · 22d
Cleared Jan 05, 1978
HEMAGGLUTINATION INHIBITION TEST
K772095
Miles Laboratories, Inc.
Immunology · 59d
Cleared Aug 03, 1977
ANTISERA TO HUMAN FAB FRAGMENT
K771242
Kent Laboratories, Inc.
Microbiology · 23d