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
K841992 ADVANCED CARDIOVASCULAR SYSTEMS, INC. MODIFICATION TO ACS CORONARY GUIDING 06/11/1984
K850586 APPLICATIONS LAB SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M 03/14/1985
K955908 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM IGM ASSAY 02/09/1996
K812487 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM 09/23/1981
K800450 ELECTRO-NUCLEONICS LABORATORIES, INC. GEMENI IGM ASSAY 04/24/1980
K982639 HELENA LABORATORIES SPIFE URINE IFE 11/04/1998
K790705 KENT LABORATORIES, INC. ANTISERUM TO HUMAN IGM 04/12/1979
K040431 ROCHE DIAGNOSTICS CORP. ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 03/10/2004


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