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FDA 510(k) Applications Submitted by WAYNE A KVETKOSKY
FDA 510(k) Number
Submission Date
Device Name
Applicant
K001525
05/16/2000
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
TRINITY BIOTECH, PLC
K993839
11/12/1999
ENA PROFILE ELISA TEST SYSTEM
TRINITY BIOTECH USA
K032194
07/18/2003
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
GEN-PROBE, INC.
K992665
08/09/1999
MACRA LP(A) ENZYME IMMUNOASSAY KIT
TRINITY BIOTECH USA
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