FDA 510(k) Applications Submitted by IVD RESEARCH, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K020583 02/21/2002 IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 IVD RESEARCH, INC.
K031059 03/28/2003 IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 IVD RESEARCH, INC.
K032897 09/17/2003 C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 IVD RESEARCH, INC.
K024113 12/13/2002 IVD CRYPTO/GIARDIA DFA IVD RESEARCH, INC.
K081064 04/14/2008 GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF IVD RESEARCH, INC.


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