INTEGRA / Helen M. Lee Siemens Healthcare Inc. / /
Facility
PR-Ab complex / / /
IndustryTerm
mledical device / in vitro diagnostic product / matrix product / automated clinical chemistry test systems / predicate devices / of'devices / Internet address / marketed predlicate devices / /
Organization
Division Sign-Off Office / Division of Postmarket Surveillance / CDRH's office of Surveillance and Biometric / Central Intelligence Agency / United Nations / In Virro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure Indications for Use Form / FDA / Division of Small Manufacturers / International and Consumer Assistance / Division of Chemistry / CDRH's office of Surveillance / Chemistry and Toxicology Office / /
K102 772 DimensionO MPAT 510 (k) Summary OCT