Back to free search
Home / Search / K020710

BIOTEST HEMOGLOBIN MEASURING SYSTEM

Biotest Medizintechnik GmbH · Class II · Cleared Aug 14, 2002

K-numberK020710
Device nameBIOTEST HEMOGLOBIN MEASURING SYSTEM
ApplicantBiotest Medizintechnik GmbH
Product codeGKR
Device classClass II
Decision dateAug 14, 2002
DecisionSubstantially Equivalent
Regulation864.5620
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 →

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

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →