Cleared Traditional

K800061 - BOND ELUT COLUMNS

K800061 is the FDA 510(k) clearance for BOND ELUT COLUMNS by Analytichem International, Inc.. It is a Class 1 Toxicology device (product code DJY) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K800061 · Analytichem International, Inc. · Toxicology device
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Mar 1980
Decision
63d
Days
Class 1
Risk

K800061 is an FDA 510(k) clearance for the BOND ELUT COLUMNS. Classified as Ion-exchange Chromatography (product code DJY), Class I - General Controls.

Submitted by Analytichem International, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2230 - 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 Analytichem International, Inc. devices

Submission Details

510(k) Number K800061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1980
Decision Date March 12, 1980
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DJY Ion-exchange Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2230
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.