FDA 510(k) Applications for Medical Device Product Code "DIE"
(Heavy Metals Control Materials)

FDA 510(k) Number Applicant Device Name Decision Date
K890721 ACTIO, INC. SHAPE-ACTIO METAL TOXICOLOGY CONTROL 04/10/1989
K990928 BIO-RAD LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 04/16/1999
K891691 BIO-RAD LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II 12/19/1989
K020610 BIO-RAD LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 04/22/2002
K863915 SHAPE PRODUCTS CO. SHAPE-ACTIO METAL TOXICOLOGY CONTROL 11/24/1986


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