DAO · Class II · 21 CFR 866.5550

FDA Product Code DAO: Igm (mu Chain Specific), Antigen, Antiserum, Control

Leading manufacturers include Roche Diagnostics Corp., Kent Laboratories, Inc. and Electro-Nucleonics Laboratories, Inc..

8
Total
8
Cleared
39d
Avg days
1979
Since

FDA 510(k) Cleared Igm (mu Chain Specific), Antigen, Antiserum, Control Devices (Product Code DAO)

8 devices
1–8 of 8
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
K040431
Roche Diagnostics Corp.
Immunology · 20d
Cleared Nov 04, 1998
SPIFE URINE IFE
K982639
Helena Laboratories
Immunology · 98d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGM ASSAY
K955908
Boehringer Mannheim Corp.
Immunology · 42d
Cleared Jun 11, 1984
MODIFICATION TO ACS CORONARY GUIDING
K841992
Advanced Cardiovascular Systems, Inc.
Immunology · 47d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
K812487
Dako Corp.
Immunology · 23d
Cleared Apr 24, 1980
GEMENI IGM ASSAY
K800450
Electro-Nucleonics Laboratories, Inc.
Immunology · 55d
Cleared Apr 12, 1979
ANTISERUM TO HUMAN IGM
K790705
Kent Laboratories, Inc.
Immunology

About Product Code DAO - Regulatory Context