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FDA 510(k)

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS

K-Number: K080910 · 2009-02-04

ApplicantBioimagene, Inc.
Decision Date2009-02-04
Product CodeNOT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS is the device name listed in this FDA 510(k) record. The listed applicant is Bioimagene, Inc.. It received FDA 510(k) clearance on 2009-02-04 under 510(k) number K080910. 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 PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS?

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Bioimagene, Inc.. The 510(k) number is K080910.

When did PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS receive FDA 510(k) clearance?

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS received FDA 510(k) clearance on 2009-02-04, under 510(k) number K080910.

Who is the listed applicant for PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS?

The FDA 510(k) record lists Bioimagene, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS?

The FDA product code for PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS 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 Bioimagene, 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.

K092333PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67K062756PATHIAM IMAGING SOFTWARE FOR HER2/NEU

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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