Back to free search
Home / Search / K861638

KINETIC ALKALINE PHOSPHATASE REAGENT KIT

Bio-Analytics Laboratories, Inc. · Class II · Cleared May 29, 1986

K-numberK861638
Device nameKINETIC ALKALINE PHOSPHATASE REAGENT KIT
ApplicantBio-Analytics Laboratories, Inc.
Product codeCJE
Device classClass II
Decision dateMay 29, 1986
DecisionSubstantially Equivalent
Regulation862.1050
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 →