510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240025Unknown

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

Ventana Medical Systems Inc, Tucson AZ / Direct, Unknown
FDA source (opens on fda.gov)

DEN240025 is the FDA 510(k) clearance record for VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001), a class II device, cleared for Ventana Medical Systems, Inc. on under FDA product code SDP (Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit). FDA's definition for product code SDP reads: "A kappa and lambda immunoglobulin light chain in situ hybridization (ISH) mRNA probe is intended as an aid in the identification of hematolymphoid neoplasms using in situ hybridization. A Kappa and Lambda ISH mRNA probe cocktail is...". FDA records list 49 510(k) clearances for Ventana Medical Systems, Inc., from to . As of , FDA records show no recalls naming DEN240025.

Clearance record

Decision date
Received
(190 days to decision)
Product code
SDP Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
Regulation
21 CFR 864.1861
Device class
Class II
Review panel
Hematology
Applicant
Ventana Medical Systems, Inc. 1910 E. Innovation Park Dr., Tucson AZ
Third party review
No

Clearances, product code SDP

Trailing 12 months

FDA records hold no clearances under product code SDP in the trailing twelve months.

FDA records show no clearances under product code SDP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SDP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260