Name: Predicase
Price: 199 USD

K-number	K013401
Device name	K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
Applicant	K-Systems, Kivex Biotec , Ltd.
Product code	MQG
Device class	Class II
Decision date	Dec 14, 2001
Decision	Substantially Equivalent
Regulation	884.6120

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 →

K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

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