Cleared Traditional

LYFO-KWIK (TM) COAGULASE PLASMA (K861312) - FDA 510(k) Clearance

Class I Hematology device.

K861312 · Micro-Bio-Logics · Hematology device
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Apr 1986
Decision
10d
Days
Class 1
Risk

K861312 is an FDA 510(k) clearance for the LYFO-KWIK (TM) COAGULASE PLASMA. Classified as Plasma, Coagulase, Human, Horse And Rabbit (product code JTL), Class I - General Controls.

Submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on April 18, 1986 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.2160 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro-Bio-Logics devices

Submission Details

510(k) Number K861312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1986
Decision Date April 18, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 113d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTL Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.