FDA 510(k) Application Details - DEN210011

Device Classification Name

  More FDA Info for this Device
510(K) Number DEN210011
Device Name Invitae Common Hereditary Cancers Panel
Applicant Invitae Corporation
1400 16th Street
San Francisco, CA 94103 US
Other 510(k) Applications for this Company
Contact Elaine Cull
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code QVU
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/29/2021
Decision Date 09/29/2023
Decision DENG -
Classification Advisory Committee -
Review Advisory Committee MG -
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact