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FDA 510(k)

VENTANA EMA PRIMARY ANDIBODY

K-Number: K940243 · 1994-09-07

ApplicantVentana Medical Systems, Inc.
Decision Date1994-09-07
Product CodeDHF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VENTANA EMA PRIMARY ANDIBODY 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 1994-09-07 under 510(k) number K940243. The device is classified under product code DHF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTANA EMA PRIMARY ANDIBODY?

VENTANA EMA PRIMARY ANDIBODY is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K940243.

When did VENTANA EMA PRIMARY ANDIBODY receive FDA 510(k) clearance?

VENTANA EMA PRIMARY ANDIBODY received FDA 510(k) clearance on 1994-09-07, under 510(k) number K940243.

Who is the listed applicant for VENTANA EMA PRIMARY ANDIBODY?

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 EMA PRIMARY ANDIBODY?

The FDA product code for VENTANA EMA PRIMARY ANDIBODY is DHF.

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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)

View all 44 devices →

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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