Name: Predicase
Price: 199 USD

K-number	K022158
Device name	IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
Applicant	Instrumentation Laboratory CO
Product code	CGA
Device class	Class II
Decision date	Sep 10, 2002
Decision	Substantially Equivalent
Regulation	862.1345

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 →

IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)

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