Cleared Traditional

K791725 - CHOLINESTERASE REAGENT (FDA 510(k) Clearance)

Class I Toxicology device.

K791725 · Gilford Diagnostics · Toxicology device
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Oct 1979
Decision
47d
Days
Class 1
Risk

K791725 is an FDA 510(k) clearance for the CHOLINESTERASE REAGENT. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3240 - the FDA toxicology 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.

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Submission Details

510(k) Number K791725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1979
Decision Date October 17, 1979
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 87d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
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.