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FDA 510(k) Applications Submitted by REMEL INC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K033479
11/03/2003
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
REMEL INC
K031834
06/13/2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
REMEL INC
K031565
05/19/2003
XPECT INFLUENZA A/B
REMEL INC
K041951
07/20/2004
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
REMEL INC
K031942
06/24/2003
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
REMEL INC
K031965
06/26/2003
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
REMEL INC
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