FDA 510(k)

VENTANA CD30 (Ber-H2) RxDx Assay

K-Number: K172471 · 2018-05-08

Decision Date2018-05-08

Product CodeDEH

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

VENTANA CD30 (Ber-H2) RxDx Assay is a medical device manufactured by Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-05-08 under approval 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. It is manufactured by Ventana Medical Systems, Inc.. The 510(k) number is K172471.

When was VENTANA CD30 (Ber-H2) RxDx Assay approved by the FDA?

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

What company makes VENTANA CD30 (Ber-H2) RxDx Assay?

VENTANA CD30 (Ber-H2) RxDx Assay is manufactured by Ventana Medical Systems, Inc..

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 Devices by Ventana Medical Systems, Inc.

DEN160019CINtec Histology (50 tests), CINtec Histology (250 tests) K212176CINtec Histology K242783Roche Digital Pathology Dx DEN240025VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) K232879Roche Digital Pathology Dx (VENTANA DP 200) PMA P160002Immunohistochemistry assay, antibody, programmed death-ligand 1

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.