Name: Predicase
Price: 199 USD

K-number	K133322
Device name	STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
Applicant	Steritec Products Mfg Co, Inc.
Product code	FRC
Device class	Class II
Decision date	Aug 25, 2014
Decision	Substantially Equivalent
Regulation	880.2800

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 →

STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

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