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FDA 510(k)

VENTANA CD30 (Ber-H2) RxDx Assay

K-Number: K172471 · 2018-05-08

ApplicantVentana Medical Systems, Inc.
Decision Date2018-05-08
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VENTANA CD30 (Ber-H2) RxDx Assay is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K172471. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTANA CD30 (Ber-H2) RxDx Assay?

VENTANA CD30 (Ber-H2) RxDx Assay is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K172471.

When did VENTANA CD30 (Ber-H2) RxDx Assay receive FDA 510(k) clearance?

VENTANA CD30 (Ber-H2) RxDx Assay received FDA 510(k) clearance on 2018-05-08, under 510(k) number K172471.

Who is the listed applicant for VENTANA CD30 (Ber-H2) RxDx Assay?

The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTANA CD30 (Ber-H2) RxDx Assay?

The FDA product code for VENTANA CD30 (Ber-H2) RxDx Assay is DEH.

Other records listing Ventana Medical Systems, Inc. as applicant

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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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