Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PAP ANTIBODY KIT

K-Number: K924629 · 1993-02-04

ApplicantVentana Medical Systems, Inc.
Decision Date1993-02-04
Product CodeDFD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PAP ANTIBODY KIT 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 1993-02-04 under 510(k) number K924629. 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 PAP ANTIBODY KIT?

PAP ANTIBODY KIT is a medical device that received FDA 510(k) clearance on 1993-02-04. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K924629.

When did PAP ANTIBODY KIT receive FDA 510(k) clearance?

PAP ANTIBODY KIT received FDA 510(k) clearance on 1993-02-04, under 510(k) number K924629.

Who is the listed applicant for PAP ANTIBODY KIT?

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 PAP ANTIBODY KIT?

The FDA product code for PAP ANTIBODY KIT 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_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 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 →

Related Devices (Code: DFD)

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.

K940242VENTANA CEA PRIMARY ANTIBODYVentana Medical Systems, Inc.K924578PSA 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.

↑