DAO · Class II · 21 CFR 866.5550

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

Leading manufacturers include Roche Diagnostics Corp., Boehringer Mannheim Corp. and Helena Laboratories.

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

About Product Code DAO - Regulatory Context