Name: Predicase
Price: 199 USD

K-number	K060364
Device name	VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
Applicant	Teco Diagnostics
Product code	JKA
Device class	Class II
Decision date	Jun 15, 2006
Decision	Substantially Equivalent
Regulation	862.1675

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 →

VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE

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