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FDA Product Code

FDA Product Code SDP — Clearance Directory

Device Class
Class II
Assigned Panel
Hematology
21 CFR Citation
864.1861

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN240025 VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) Ventana Medical Systems, Inc. 2024-12-05 Direct —

Product code SDP · Class II · Hematology. Data: openFDA.