Cleared Traditional

K760975 - WEIL ONCOMETER (IL 186)

K760975 is the FDA 510(k) clearance for WEIL ONCOMETER (IL 186) by Instrumentation Laboratory CO. It is a Class 1 Chemistry device (product code JJK) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K760975 · Instrumentation Laboratory CO · Chemistry device
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Jan 1977
Decision
70d
Days
Class 1
Risk

K760975 is an FDA 510(k) clearance for the WEIL ONCOMETER (IL 186). Classified as Oncometer, Plasma, For Clinical Use (product code JJK), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on January 12, 1977 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2720 - the FDA in vitro diagnostics and chemistry 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.

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Submission Details

510(k) Number K760975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1976
Decision Date January 12, 1977
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJK Oncometer, Plasma, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2720
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.