Radiological Health / In Vitro Diagnostics / ARKRAY Factory USA Inc. / kI21456 Trade / ARKRAY Inc. / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
announcements concerning your device / predicate devices / integrated device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / cleared predicate devices / matrix solution / Internet address http /
Organization
Food and Drug Administration / HEALTH Public Health Service / African Union / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use / Division of Postm-arket Surveillance / Division of Small Manufacturers / International and Consumer Assistance / New Hampshire Avenue Document Control Center / Division of Chemistry / CDRH's office of Surveillance / Chemistry and Toxicology Devices Office / /
Person
Ruth A. Chesler / Ruth A. Cheslerl / Adam EtlI / Courtney H. Lias / MAX AX / Carol C.Benson / Adam Etti / / /
Ca r~raFEB[removed]k) Summary Date Prepared: