FDA 510(k) Applications for Medical Device Product Code "LKT"
(Respiratory Syncytial Virus, Antigen, Antibody, Ifa)

FDA 510(k) Number Applicant Device Name Decision Date
K081928 DIAGNOSTIC HYBRIDS, INC. D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT 12/23/2008
K983336 DIAGNOSTIC PRODUCTS CORP. PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 03/18/1999


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