Name: Predicase
Price: 199 USD

K-number	K021023
Device name	HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
Applicant	Instrumentation Laboratory CO
Product code	GGN
Device class	Class II
Decision date	May 14, 2002
Decision	Substantially Equivalent
Regulation	864.5425

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 →

HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)

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