Name: Predicase
Price: 199 USD

K-number	K143526
Device name	The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
Applicant	Thermo Fisher Scientific
Product code	JWY
Device class	Class II
Decision date	Mar 5, 2015
Decision	Substantially Equivalent
Regulation	866.1640

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 →

The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)

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