ICR Documents

Supporting Statement A Document Date Uploaded 0073_Supporting Statement_2019.doc 11/15/2019 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Proposed Device Reclassification HIV Tests HIV Proposed Reclassification Feb 21 2020.pdf Supplementary Document 02/26/2021 Change Request for HIV test devices 0073 Change Request for HIV device Feb 2021.docx Justification for No Material/Nonsubstantive Change 02/26/2021 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received