Roche Diagnostics Inc. / Ammirati Regulatory Consulting / 9 Q* Hitachi Chemical Diagnostics Inc. / CVs / Hitachl Chemical Diagnostics Inc. / Chemical Diagnostics Inc. / C/O Erika Ammirati / 9 oHitachi Chemical Diagnostics Inc. / K 130685 Trade / Hitachi Chemical Diagnostics Inc. / Hitatchi Chemical Diagnostics Inc. / Hitacl I Chemical Diagnostics Inc. / /
Event
FDA Phase / /
Facility
Clye Court / Clyde Court / / /
IndustryTerm
test systems / announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / treatment of pancreatic diseases / /
Inspire the Next SECTION[removed]k) SUMMARY This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CER[removed]The assigned 510(k)