Cleared Traditional

QUANTIMETRIC 2 TEST KIT (K813242) - FDA 510(k) Clearance

Class I Immunology device.

K813242 · Kallestad Laboratories, Inc. · Immunology device
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Dec 1981
Decision
15d
Days
Class 1
Risk

K813242 is an FDA 510(k) clearance for the QUANTIMETRIC 2 TEST KIT. Classified as Slides, Microscope (product code KEW), Class I - General Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.3010 - the FDA immunology 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K813242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1981
Decision Date December 02, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 104d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEW Slides, Microscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3010
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.