TY - GEN AU - Smith,K M AU - Kates,J A TI - Regulatory hurdles in bringing an in vitro diagnostic device to market SN - 0009-9147 PY - 1996///1022 KW - Consumer Product Safety KW - Equipment and Supplies KW - standards KW - Reagent Kits, Diagnostic KW - United States KW - United States Food and Drug Administration N1 - Publication Type: Journal Article ER -