Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - DEN200001
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN200001
Device Name
Cell-Free DNA BCT
Applicant
Streck, Inc.
7002 S. 109th Street
La Vista, NE 68128 US
Other 510(k) Applications for this Company
Contact
Deborah Kipp
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QMA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2020
Decision Date
08/07/2020
Decision
DENG -
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact