Adaptive Biotechnologies clonoSEQ Assay
K-Number: K200009 · 2020-08-05
ApplicantAdaptive Biotechnologies Corporation
Decision Date2020-08-05
Product CodeQDC
Advisory CommitteePA
DecisionSubstantially Equivalent
Device Summary
Adaptive Biotechnologies clonoSEQ Assay is a medical device manufactured by Adaptive Biotechnologies Corporation. It received FDA 510(k) clearance on 2020-08-05 under approval number K200009. The device is classified under product code QDC. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Adaptive Biotechnologies clonoSEQ Assay?
Adaptive Biotechnologies clonoSEQ Assay is a medical device that received FDA 510(k) clearance on 2020-08-05. It is manufactured by Adaptive Biotechnologies Corporation. The 510(k) number is K200009.
When was Adaptive Biotechnologies clonoSEQ Assay approved by the FDA?
Adaptive Biotechnologies clonoSEQ Assay received FDA 510(k) clearance on 2020-08-05, under approval number K200009.
What company makes Adaptive Biotechnologies clonoSEQ Assay?
Adaptive Biotechnologies clonoSEQ Assay is manufactured by Adaptive Biotechnologies Corporation.
What is the FDA product code for Adaptive Biotechnologies clonoSEQ Assay?
The FDA product code for Adaptive Biotechnologies clonoSEQ Assay is QDC.
Other Devices by Adaptive Biotechnologies Corporation
Related Devices (Code: QDC)
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.