Name: Predicase
Price: 199 USD

K-number	K900009
Device name	NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
Applicant	Kallestad Diag, A Div. of Erbamont, Inc.
Product code	KLS
Device class	Class II
Decision date	Mar 29, 1990
Decision	Substantially Equivalent
Regulation	862.3880

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 →

NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET

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