FDA 510(k) Applications for Medical Device Product Code "CGM"
(Method, Immunodiffusion, Immunoglobulins (G, A, M))

FDA 510(k) Number Applicant Device Name Decision Date
K920006 INSTRUMENTATION LABORATORY CO. IL TEST IMMUNOGLOBULIN G (IGG) 03/13/1992
K920008 INSTRUMENTATION LABORATORY CO. IL TEST IMMUNOGLOBULIN M (IGM) 03/11/1992
K920370 ISOTYPES, INC. ISOTYPES HUMAN IGG SUBCLASS EIA KIT 03/11/1992
K915650 JANSSEN BIOCHIMICA HUMAN IGG SUBCLASS RID KIT 03/26/1992


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