FDA 510(k)

VENTANA CEA PRIMARY ANTIBODY

K-Number: K940242 · 1996-12-23

Decision Date1996-12-23

Product CodeDFD

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

VENTANA CEA 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 1996-12-23 under 510(k) number K940242. The device is classified under product code DFD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTANA CEA PRIMARY ANTIBODY?

VENTANA CEA PRIMARY ANTIBODY is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K940242.

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

VENTANA CEA PRIMARY ANTIBODY received FDA 510(k) clearance on 1996-12-23, under 510(k) number K940242.

Who is the listed applicant for VENTANA CEA 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 CEA PRIMARY ANTIBODY?

The FDA product code for VENTANA CEA PRIMARY ANTIBODY is DFD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ventana Medical Systems, Inc. as applicant

K242783Roche Digital Pathology Dx K232879Roche Digital Pathology Dx (VENTANA DP 200)K212176CINtec Histology K172471VENTANA CD30 (Ber-H2) RxDx Assay K130515VIRTUOSO SYSTEM FOR IHC ER (SPI)K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

View all 44 devices →

Related Devices (Code: DFD)

K924578PSA ANTIBODY KITVentana Medical Systems, Inc.K924629PAP ANTIBODY KITVentana Medical Systems, Inc.

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.