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

FDA 510(k) Number Applicant Device Name Decision Date
K831902 DAKO CORP. FLUORESCEIN CONJUGATED IMMUNOGLOBIN- 07/18/1983
K050576 GOOD BIOTECH CORP. MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H 04/21/2005
K023860 POINTE SCIENTIFIC, INC. MICROALBUMIN REAGENT SET AND CALIBRATORS 04/28/2003
K002674 RANDOX LABORATORIES, LTD. RANDOX MICROALBUMIN 10/05/2000


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