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

FDA 510(k) Number Applicant Device Name Decision Date
K972638 BOEHRINGER MANNHEIM CORP. TINA-QUANT PREALBUMIN 01/09/1998
K000661 RANDOX LABORATORIES, LTD. RANDOX PREALBUMIN 04/13/2000


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