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FDA 510(k)

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

K-Number: K101234 · 2011-08-25

ApplicantVentana Medical Systems, Inc.
Decision Date2011-08-25
Product CodeOWF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY 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 2011-08-25 under 510(k) number K101234. The device is classified under product code OWF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY?

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY is a medical device that received FDA 510(k) clearance on 2011-08-25. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K101234.

When did VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY receive FDA 510(k) clearance?

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY received FDA 510(k) clearance on 2011-08-25, under 510(k) number K101234.

Who is the listed applicant for VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY?

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 ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY?

The FDA product code for VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY is OWF.

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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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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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