Name: Predicase
Price: 199 USD

K-number	K070819
Device name	VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
Applicant	Bio-Rad Laboratories Inc., Clinical Systems Divisi
Product code	LCP
Device class	Class II
Decision date	Jun 25, 2007
Decision	Substantially Equivalent
Regulation	864.7470

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 →

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,

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