Name: Predicase
Price: 199 USD

K-number	K101564
Device name	CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
Applicant	Centers for Disease Control and Prevention
Product code	OQW
Device class	Class II
Decision date	Jun 22, 2010
Decision	Substantially Equivalent
Regulation	866.3332

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 →

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL

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