Cell-Free DNA BCT
K-Number: K231776 · 2024-07-26
ApplicantStreck, Inc.
Decision Date2024-07-26
Product CodeQMA
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Cell-Free DNA BCT is a medical device manufactured by Streck, Inc.. It received FDA 510(k) clearance on 2024-07-26 under approval number K231776. The device is classified under product code QMA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cell-Free DNA BCT?
Cell-Free DNA BCT is a medical device that received FDA 510(k) clearance on 2024-07-26. It is manufactured by Streck, Inc.. The 510(k) number is K231776.
When was Cell-Free DNA BCT approved by the FDA?
Cell-Free DNA BCT received FDA 510(k) clearance on 2024-07-26, under approval number K231776.
What company makes Cell-Free DNA BCT?
Cell-Free DNA BCT is manufactured by Streck, Inc..
What is the FDA product code for Cell-Free DNA BCT?
The FDA product code for Cell-Free DNA BCT is QMA.
Other Devices by Streck, Inc.
Related Devices (Code: QMA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.