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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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