announcements concerning your device / predicate device / manufacturing practice requirements / Internet address http /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Surveillance / Radiological Health Center for Devices and Radiological Health Enclosure / Division of Small Manufacturers / International and Consumer Assistance / New Hampshire Avenue Document Control Center / Division of Chemistry / Chemistry and Toxicology Devices Office / /
JAN[removed]k) Summary of Safety and Effectiveness for the ADVIA® Chemistry Fructosamine (FRUC) Assay and Calibrator This summary of 51O(k) safety and effectiveness informnation is being submitted in accordance wi