FDA 510(k) Applications for Medical Device Product Code "DEL"
(Lipoprotein X, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K893885 CATACHEM, INC. BACTON TM, BASIC TM, APO A-I REAGENT 06/21/1989
K895160 MEDICAL MARKETING CONSULTANTS, INC. ORTHO *APO A-1 ELISA TEST SYSTEM 10/06/1989
K013278 ROCHE DIAGNOSTICS CORP. TINA-QUANT APOLIPOPROTEIN A-1 VER.2 11/15/2001
K901675 SIGMA CHEMICAL CO. APOLIPOPROTEIN A-I (APO A-I) 04/26/1990
K900124 SIGMA CHEMICAL CO. APOLIPOPROTEIN B (APO B) 03/02/1990


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact