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FDA 510(k)

ARIOL HER-2/NEU IHC

K-Number: K031715 · 2004-01-08

ApplicantApplied Imaging Corp.
Decision Date2004-01-08
Product CodeNOT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ARIOL HER-2/NEU IHC is the device name listed in this FDA 510(k) record. The listed applicant is Applied Imaging Corp.. It received FDA 510(k) clearance on 2004-01-08 under 510(k) number K031715. The device is classified under product code NOT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIOL HER-2/NEU IHC?

ARIOL HER-2/NEU IHC is a medical device that received FDA 510(k) clearance on 2004-01-08. The listed applicant is Applied Imaging Corp.. The 510(k) number is K031715.

When did ARIOL HER-2/NEU IHC receive FDA 510(k) clearance?

ARIOL HER-2/NEU IHC received FDA 510(k) clearance on 2004-01-08, under 510(k) number K031715.

Who is the listed applicant for ARIOL HER-2/NEU IHC?

The FDA 510(k) record lists Applied Imaging Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIOL HER-2/NEU IHC?

The FDA product code for ARIOL HER-2/NEU IHC is NOT.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Applied Imaging Corp. 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.

K043519ARIOL HER-2/NEU FISHK042542CYTOVISION FOR CEP XYK033200ARIOLK001420SLIDESCANK980375WINSCAN AUTOMATED IMAGING SYSTEMK902311GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.

View all 7 devices →

Related Devices (Code: NOT)

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.

K260755OptraSCAN SystemOptrascan, Inc.K121033VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.K121350VIRTUSO SYSTEM FOR IHC (DO-7)Ventana Medical Systems, Inc.K111755VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.K111543VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.K080564SCANSCOPE 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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