Cleared Traditional

K791431 - TECHNICON FAST-LC SYS. FOR THEOPHYLLINE (FDA 510(k) Clearance)

Class I Toxicology device.

K791431 · Technicon Instruments Corp. · Toxicology device
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Oct 1979
Decision
77d
Days
Class 1
Risk

K791431 is an FDA 510(k) clearance for the TECHNICON FAST-LC SYS. FOR THEOPHYLLINE. Classified as Apparatus, General Use, Thin Layer Chromatography (product code DPA), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on October 11, 1979 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2270 - 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.

View all Technicon Instruments Corp. devices

Submission Details

510(k) Number K791431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1979
Decision Date October 11, 1979
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 87d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DPA Apparatus, General Use, Thin Layer Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2270
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.