FDA 510(k) Applications for Medical Device Product Code "LGJ"
(Fluorescence Polarization Immunoassay, Amibacin)

FDA 510(k) Number Applicant Device Name Decision Date
K991597 ROCHE DIAGNOSTICS CORP. COBAS INTEGRA AMIKACIN MAB 07/22/1999


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact