Cleared Traditional

VENTANA CD30 (Ber-H2) RxDx Assay

K172471 · Ventana Medical Systems, Inc. · Medical Genetics
May 2018
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K172471 is an FDA 510(k) clearance for the VENTANA CD30 (Ber-H2) RxDx Assay, a Lambda, Antigen, Antiserum, Control (Class II — Special Controls, product code DEH), submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on May 8, 2018, 266 days after receiving the submission on August 15, 2017. This device falls under the Medical Genetics review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K172471 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2017
Decision Date May 08, 2018
Days to Decision 266 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF

Device Classification

Product Code DEH — Lambda, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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