ICR Documents

Supporting Statement A Document Date Uploaded 0120 Premarket Notification SSA 2023 REV.docx 06/29/2023 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded 0120 eSTAR Change Request 0889 and 0120 eSTAR Change Request SEPT 2021 Final.docx Justification for No Material/Nonsubstantive Change 09/10/2021 Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based in Vitro Diagnostics 83-C for 0120 to add 0850 Genetic Variant Databases AUG 2023.docx Justification for No Material/Nonsubstantive Change 08/27/2023 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received