Name: Predicase
Price: 199 USD

K-number	K132909
Device name	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
Applicant	Becton, Dickinson and Company
Product code	LON
Device class	Class II
Decision date	Feb 14, 2014
Decision	Substantially Equivalent
Regulation	866.1645

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 →

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)

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