Name: Predicase
Price: 199 USD

K-number	K063145
Device name	PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
Applicant	Thermo Electron OY
Product code	DIP
Device class	Class II
Decision date	Oct 17, 2007
Decision	Substantially Equivalent
Regulation	862.3350

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 →

PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

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