VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

K Number: DEN240025 · Decision Dec 5, 2024

Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

Review Days

190

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Device Name: VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
K Number: DEN240025
Device Class: FDA class 2
Clearance Type: Direct
Regulation Number: 864.1861
Medical Specialty: Hematology
Decision: Unknown
Applicant: Ventana Medical Systems, Inc.
Date Received: May 29, 2024
Decision Date: December 5, 2024
Product Code: SDP
Advisory Committee: Hematology
Review Advisory Committee: PA
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
SDP	Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit	FDA class 2	Hematology

K Number	Device Name	Decision Date	Decision
K242783	Roche Digital Pathology Dx	Dec 17, 2024	Substantially Equivalent
K232879	Roche Digital Pathology Dx (VENTANA DP 200)	Jun 14, 2024	Substantially Equivalent
K212176	CINtec Histology	Dec 10, 2021	Substantially Equivalent
K172471	VENTANA CD30 (Ber-H2) RxDx Assay	May 8, 2018	Substantially Equivalent
DEN160019	CINtec Histology (50 tests), CINtec Histology (250 tests)	Mar 4, 2017	Unknown
K142965	Virtuoso System for IHC PR (1E2) using iScan HT	Jul 16, 2015	Substantially Equivalent
K140465	VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER	Mar 20, 2014	Substantially Equivalent
K130515	VIRTUOSO SYSTEM FOR IHC ER (SPI)	Nov 22, 2013	Substantially Equivalent
K121516	VIRTUOSO SYSTEM FOR IHC HER2 (4B5)	Sep 26, 2013	Substantially Equivalent
K122143	VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER	Sep 19, 2013	Substantially Equivalent