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FDA 510(k)

VIRTUOSO SYSTEM FOR IHC PR (IE2)

K-Number: K111869 · 2012-03-05

ApplicantVentana Medical Systems, Inc.
Decision Date2012-03-05
Product CodeNQN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VIRTUOSO SYSTEM FOR IHC PR (IE2) 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 2012-03-05 under 510(k) number K111869. The device is classified under product code NQN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRTUOSO SYSTEM FOR IHC PR (IE2)?

VIRTUOSO SYSTEM FOR IHC PR (IE2) is a medical device that received FDA 510(k) clearance on 2012-03-05. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K111869.

When did VIRTUOSO SYSTEM FOR IHC PR (IE2) receive FDA 510(k) clearance?

VIRTUOSO SYSTEM FOR IHC PR (IE2) received FDA 510(k) clearance on 2012-03-05, under 510(k) number K111869.

Who is the listed applicant for VIRTUOSO SYSTEM FOR IHC PR (IE2)?

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 VIRTUOSO SYSTEM FOR IHC PR (IE2)?

The FDA product code for VIRTUOSO SYSTEM FOR IHC PR (IE2) is NQN.

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Other records listing Ventana Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242783Roche Digital Pathology DxK232879Roche Digital Pathology Dx (VENTANA DP 200)K212176CINtec HistologyK172471VENTANA CD30 (Ber-H2) RxDx AssayK130515VIRTUOSO SYSTEM FOR IHC ER (SPI)K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

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Related Devices (Code: NQN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130515VIRTUOSO SYSTEM FOR IHC ER (SPI)Ventana Medical Systems, Inc.K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.K122143VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINERVentana Medical Systems, Inc.K111872VIRTUOSO SYSTEM FOR IHC P53 (DO-7)Ventana Medical Systems, Inc.K092333PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67Bioimagene, Inc.K073677SCANSCOPE XT SYSTEMAperio Technologies

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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