Cleared Traditional

MINIFUGE, MODEL 70 (K882149) - FDA 510(k) Clearance

Class I Hematology device.

K882149 · Utah Bioresearch, Inc. · Hematology device
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Jul 1988
Decision
39d
Days
Class 1
Risk

K882149 is an FDA 510(k) clearance for the MINIFUGE, MODEL 70. Classified as Antigen, Latex Agglutination, Trichinella Spiralis (product code GPG), Class I - General Controls.

Submitted by Utah Bioresearch, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.3850 - 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 Utah Bioresearch, Inc. devices

Submission Details

510(k) Number K882149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1988
Decision Date July 01, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 113d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GPG Antigen, Latex Agglutination, Trichinella Spiralis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3850
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.