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FDA 510(k)

KERATIN PRIMARY ANTIBODY

K-Number: K940331 · 1996-02-26

ApplicantVentana Medical Systems, Inc.
Decision Date1996-02-26
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KERATIN 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 1996-02-26 under 510(k) number K940331. 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 KERATIN PRIMARY ANTIBODY?

KERATIN PRIMARY ANTIBODY is a medical device that received FDA 510(k) clearance on 1996-02-26. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K940331.

When did KERATIN PRIMARY ANTIBODY receive FDA 510(k) clearance?

KERATIN PRIMARY ANTIBODY received FDA 510(k) clearance on 1996-02-26, under 510(k) number K940331.

Who is the listed applicant for KERATIN 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 KERATIN PRIMARY ANTIBODY?

The FDA product code for KERATIN PRIMARY ANTIBODY is DEH.

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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: DEH)

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.

K172471VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc.K083601LAMBDA LIGHT CHAINSSENTINEL CH. SpAK033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERThe Binding Site, Ltd.K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIThe Binding Site, Ltd.K023131FREELITE HUMAN LAMBDA FREE KITThe Binding Site, Ltd.K010440FREELITE LAMBDA FREE KITThe Binding Site, Ltd.

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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