FDA 510(k) Applications for Medical Device Product Code "DAK"
(Complement C1q, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K012576 AMERICAN LABORATORY PRODUCTS CO., LTD. CIC-C1Q EIA 01/29/2002
K032254 IBL GMBH IBL C1Q-CIC CIA TEST 08/29/2003
K972873 IMMUNOMEDICS, INC. IMMUSTRIP HAMA IGG 03/17/1998
K973203 SANGSTAT MEDICAL CORP. THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES 09/30/1998
K031563 THE BINDING SITE, LTD. BINDAZYME CLQ CIC EIA KIT 09/10/2003


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