FDA 510(k) Applications for Medical Device Product Code "DDS"
(Prealbumin, Fitc, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K854811 BECKMAN INSTRUMENTS, INC. ICS PAB PREALBUMIN REAGENT TEST KIT 01/24/1986
K964781 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT 05/09/1997
K972812 HEMAGEN DIAGNOSTICS, INC. RAICHEM PREALBUMIN SPIA 08/28/1997
K934966 INCSTAR CORP. SPQ PAL CONTROL LEVEL II 01/11/1994


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