Name: Predicase
Price: 199 USD

K-number	K202304
Device name	NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
Applicant	Nyu Langone Medical Center
Product code	PZM
Device class	Class II
Decision date	Jul 14, 2021
Decision	Substantially Equivalent
Regulation	866.6080

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

Everything you need for a 510(k) submission. Nothing you don't.