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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Adaptive Biotechnologies Corporation. It received FDA 510(k) clearance on 2020-08-05 under 510(k) 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. The listed applicant is Adaptive Biotechnologies Corporation. The 510(k) number is K200009.

When did Adaptive Biotechnologies clonoSEQ Assay receive FDA 510(k) clearance?

Adaptive Biotechnologies clonoSEQ Assay received FDA 510(k) clearance on 2020-08-05, under 510(k) number K200009.

Who is the listed applicant for Adaptive Biotechnologies clonoSEQ Assay?

The FDA 510(k) record lists Adaptive Biotechnologies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adaptive Biotechnologies clonoSEQ Assay?

The FDA product code for Adaptive Biotechnologies clonoSEQ Assay is QDC.

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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.

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