manufacturing practice requirements / marketed predicate devices / manufacturing practice / announcements concerning your device / Internet address http /
MedicalCondition
kidney diseases / /
Organization
Division Sign-Off Office / In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure Indications for Use / Food and Drug Administration / Division of Small Manufacturers / DEPARTMENT OF HEALTH / Division of Chemistry / CDRH's office of Surveillance / Chemistry and Toxicology Office / / /
Position
Calibrator / pALB calibrator / Photios NMakris Director of Regulatory Affairs / Director / /