FDA 510(k) Applications for Medical Device Product Code "DAO"
(Igm (Mu Chain Specific), Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K955908 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM IGM ASSAY 02/09/1996
K982639 HELENA LABORATORIES SPIFE URINE IFE 11/04/1998
K040431 ROCHE DIAGNOSTICS CORP. ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 03/10/2004


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