Cleared Traditional

K821875 - ULTRACHEM TRI-ES

K821875 is the FDA 510(k) clearance for ULTRACHEM TRI-ES by Harleco Diagnostics. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K821875 · Harleco Diagnostics · Chemistry device
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Jul 1982
Decision
18d
Days
Class 1
Risk

K821875 is an FDA 510(k) clearance for the ULTRACHEM TRI-ES. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Harleco Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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.

View all Harleco Diagnostics devices

Submission Details

510(k) Number K821875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1982
Decision Date July 13, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
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.

Regulatory Peers - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 113
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K821875.
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K812471 · Smithkline Diagnostics, Inc. · Sep 1981
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